Department of Health and Human Services - GPO 19, 2001 · Department of Health and Human Services ... Operating Procedures D. Hazard Analysis ... processing of citrus juice and juice

Friday,

January 19, 2001

Part V

Department ofHealth and HumanServicesFood and Drug Administration

21 CFR Part 120Hazard Analysis and Critical ControlPoint (HAACP); Procedures for the Safeand Sanitary Processing and Importing ofJuice; Final Rule

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6138 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

1 As defined in § 120.1 (21 CFR 120.1) ‘‘juice’’refers both to beverages that are composedexclusively of an aqueous liquid or liquidsextracted from one or more fruits or vegetables andto the juice ingredient in those beverages thatcontain other ingredients in addition to juice. Inthis document, the term ‘‘juice product’’ refers bothto beverages that contain only juice and to the juiceingredient of beverages that are composed of juiceand other ingredients.

In the remainder of this document, products notprocessed to prevent, reduce, or eliminate hazardswill be referred to as ‘‘untreated juice products.’’ Inaddition, processing to ‘‘prevent, reduce, oreliminate’’ hazards will be referred to as processingto ‘‘control’’ hazards.

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

21 CFR Part 120

[Docket No. 97N–0511]

RIN 0910–AA43

Hazard Analysis and Critical ControlPoint (HAACP); Procedures for theSafe and Sanitary Processing andImporting of Juice

AGENCY: Food and Drug Administration,HHS.ACTION: Final rule.

SUMMARY: The Food and DrugAdministration (FDA or the agency) isadopting final regulations to ensure thesafe and sanitary processing of fruit andvegetable juices. The regulationsmandate the application of HazardAnalysis and Critical Control Point(HACCP) principles to the processing ofthese foods. HACCP is a preventivesystem of hazard control. FDA is takingthis action because there have been anumber of food hazards associated withjuice products and because a system ofpreventive control measures is the mosteffective and efficient way to ensure thatthese products are safe.DATES: Effective Dates: This rule iseffective January 22, 2002.

Compliance Date: For smallbusinesses as defined in 21 CFR120.1(b)(1), the final rule will bebinding January 21, 2003. For very smallbusinesses as defined in 21 CFR120.1(b)(2), the final rule will bebinding January 20, 2004.FOR FURTHER INFORMATION CONTACT:Shellee Anderson, Center for FoodSafety and Applied Nutrition (HFS–366), Food and Drug Administration,200 C St. SW., Washington, DC 20204,202–205–5023.SUPPLEMENTARY INFORMATION:

Table of Contents

I. BackgroundA. Notice of IntentB. The ProposalC. Additional Opportunities for Public

ParticipationD. NACMCF Public Meeting

II. Response to the CommentsA. Alternatives to HACCP Considered by

the AgencyB. Response to the Decision to Propose

HACCPC. Significance of Illness DataD. Comparison of the Proposal and this

Final RegulationIII. The Final Regulation

A. ApplicabilityB. Definitions

C. Prerequisite Program StandardOperating Procedures

D. Hazard AnalysisE. HACCP PlanF. Legal BasisG. Corrective ActionsH. Verification and ValidationI. RecordsJ. TrainingK. Application of Requirements to

Imported ProductsL. Process ControlsM. HACCP Enforcement IssuesN. Miscellaneous Issues

IV. Effective DateV. Final Regulatory Impact Analysis

A. IntroductionB. Factors Considered in Developing This

AnalysisC. BenefitsD. CostsE. Summary of Benefits and Costs

VI. Regulatory Flexibility AnalysisA. ObjectivesB. Definition of Small Business and

Number of Small Businesses AffectedC. Description of the Impact on Small

EntitiesD. Minimizing the Burden on Small

EntitiesE. Summary

VII. Paperwork Reduction Act of 1995VIII. Environmental ImpactIX. FederalismX. References

I. Background

A. Notice of IntentIn the Federal Register of August 28,

1997 (62 FR 45593)(Ref. 1), FDApublished a notice of intent (hereinafterreferred to as the notice of intent) thatannounced a comprehensive program toaddress the incidence of foodborneillness related to consumption of freshjuice and ultimately to address thesafety of all juice products. In the noticeof intent, the agency invited commenton the appropriateness of its strategy to:(1) Initiate rulemaking on a mandatoryHACCP program for some or all juiceproducts; (2) propose that the labels orthe labeling of juice products notspecifically processed to prevent,reduce, or eliminate pathogens bear awarning statement informing consumersof the risk of illness associated withconsumption of the product; and (3)initiate several educational programs tominimize the hazards associated withconsumption of fresh juices. The agencystated that it would address commentsreceived within 15 days of publicationof the notice of intent as part of any ruleproposed by the agency. FDA also statedthat it would consider all comments tothe notice of intent received after 15days in any final rulemaking. FDAreviewed all of the comments receivedwithin 15 days of publication and foundthat they provided no information thatwould cause the agency to conclude that

the HACCP proposal was inappropriate.Comments received 15 days afterpublication of the notice of intent arediscussed in this final rule.

B. The ProposalIn the Federal Register of April 24,

1998 (63 FR 20450) (Ref. 2), FDApublished a proposed rule to establishrequirements relating to the processingof juice and juice products (hereinafterreferred to as the HACCP proposal).1The proposal would have required theapplication of HACCP principles byprocessors and importers to ensure juicesafety to the maximum extentpracticable. FDA proposed theseregulations because there had been anumber of food hazards, including somedirectly affecting children, associatedwith juice products. The agencytentatively concluded that the mosteffective way to ensure the safety ofjuice products is to process the productsunder a system of preventive controlmeasures based on HACCP principles.Interested persons were given until July8, 1998, to comment on the HACCPproposal. The agency subsequentlyextended the comment period to August7, 1998 (63 FR 37057; July 8, 1998) (Ref.3).

In addition to publishing the HACCPproposal, FDA published in the sameissue of the Federal Register (63 FR20486) (Ref. 4) a proposed rule (the juicelabeling proposal) to require warninglabels on juice that has not beenprocessed to prevent, reduce toacceptable levels, or eliminatepathogens that may be present. As fullydiscussed in the juice labeling proposal,FDA proposed that untreated juiceproducts bear a warning statementinforming at risk consumers of thehazard posed by untreated juices toallow them to make informed decisionson whether to purchase and consumesuch products. The labeling proposalwas finalized on July 8, 1998 (63 FR37030) (Ref. 5).

FDA issued in the Federal Register ofMay 1, 1998 (63 FR 24254) (Ref. 6) asingle Preliminary Regulatory ImpactAnalysis (PRIA) that addressed both the


6139Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

2 Although the terms ‘‘apple cider’’ and ‘‘applejuice’’ may have different meanings throughout theUnited States, these terms are used interchangeablythroughout this final rule.

juice labeling proposal and the juiceHACCP proposal. Interested partieswere given until May 26, 1998, tocomment on aspects of the PRIA relatingto the juice labeling proposal and untilJuly 8, 1998, to comment on aspects ofthe PRIA relating to the juice HACCPproposal.

C. Additional Opportunities for PublicParticipation

Under the juice labeling rule(§ 101.17(g) (21 CFR 101.17(g))), juiceand juice products that have not beenspecifically processed to attain a 5-logreduction in the pertinent pathogenmust bear a warning label. Similarly,under the juice HACCP proposal(proposed § 120.24), covered processorsmust attain a 5-log reduction in thepertinent pathogen in their HACCPsystems. Accordingly, in November1998, FDA held two technicalworkshops on how processors couldattain a 5-log (i.e., 105) reduction in thepertinent pathogen in citrus juices (63FR 57594; October 28, 1998) (Ref. 7).The transcripts from the two workshopswere placed on display in the docket forthe juice HACCP proposal and on theFDA/CFSAN website http://www.fda.gov/). On December 17, 1998(63 FR 69579) (Ref. 8), the commentperiod for the juice HACCP proposalwas reopened until January 19, 1999, toallow public comment on data and otherinformation that were presented at ordeveloped as a result of theseworkshops. In addition, FDA expresslysought comments on the following fourspecific topics related to the applicationof the 5-log pathogen reductionstandard: (1) Appropriate baselines forthe calculation of the 5-log pathogenreduction; (2) feasible interventions orpractices for the cultivation and harvestof fruits and vegetables, and acquisitionof supplies and materials that maycontribute to achieving a 5-log pathogenreduction; (3) feasible interventions forthe production process that maycontribute to achieving a 5-log pathogenreduction; and (4) acceptable methodsfor measuring and validating 5-logreductions.

On July 15 and 16, 1999, FDA held aworkshop on food safety controls for theapple cider 2 industry (64 FR 34125;June 25, 1999) (Ref. 9). The workshopdealt with issues related to theimplementation of the agency’sregulations requiring a warningstatement for certain juice products.Specifically, the workshop addressed

pathogen reduction interventions thatmay be effective for apple ciderproduction and the methods used tomeasure and validate suchinterventions. Results of researchconducted by Federal, State, private,and academic institutions werepresented.

In the Federal Register of November23, 1999 (64 FR 65669) (Ref. 10), FDAannounced the availability of new dataand information regarding the safeprocessing of citrus juice and juiceproducts, and reopened the commentperiod for the juice HACCP proposaluntil January 24, 2000, in order toreceive comment on the new data andother information. In that same notice,in order to develop the most completeadministrative record possible, FDArequested additional data andinformation relating to four separateareas: Internalization and survival ofpathogens in produce used to producejuice, especially citrus fruit; applicationand measurement of the 5-log reductionstandard; current methods used by juiceprocessors to monitor the application ofheat treatment to juice; and certaineconomic matters related to juiceregulation. The notice discussed indetail the particular issues in each of thefour areas in which the agency wasseeking comments (64 FR 65669 at65670 through 65671). Two of theseareas (internalization and survival ofpathogens and application andmeasurement of the 5-log reductionstandard) were also to be the subject ofthe December 8 to 9, 1999, publicmeeting of the National AdvisoryCommittee on Microbiological Criteriafor Foods (NACMCF) (discussed in moredetail below), and the comment periodextension was established so as topermit comments on the identifiedissues in light of any information orrecommendations coming out of thatmeeting of the NACMCF.

D. NACMCF Public MeetingNACMCF is an advisory committee

chartered under the U.S. Department ofAgriculture (USDA) and has membersfrom USDA (Food Safety and InspectionService), the Department of Health andHuman Services (U.S. Food and DrugAdministration and the Centers forDisease Control and Prevention (CDC)),the Department of Commerce (NationalMarine Fisheries Service), theDepartment of Defense (Office of theArmy Surgeon General), academia,industry and State agencies. TheNACMCF provides guidance andrecommendations to the Secretary ofAgriculture and the Secretary of Healthand Human Services regarding themicrobiological safety of foods.

The NACMCF held a public meetingon December 8 to 9, 1999 (64 FR 63281;November 19, 1999) (Refs. 11 and 12) todiscuss recent research and otherinformation related to performancecriteria for fresh citrus juices. FDAsought advice from the NACMCF on twoissues. In addition, the meeting agendaprovided an opportunity for publiccomment.

First, FDA asked the NACMCF aboutthe potential internalization andsurvival of pathogens in citrus fruits andcitrus juices. The NACMCF membersgenerally agreed that it is theoreticallypossible for microorganisms to enter theinterior of apparently sound, intactcitrus fruit under certain conditions(e.g., temperature difference betweenfruit and wash water), and that humanpathogens appear to be able to survive,at least under defined laboratoryconditions, in the fruit itself (Ref. 12).However, the NACMCF membersconcluded, based on the currentinformation, that the potential formicroorganisms to enter and survive inintact fruit is not likely to result in asignificant public health risk. Inparticular, the Committee membersconcluded, based upon the limited dataavailable, including data presented bythe industry, that although it istheoretically possible, it is unlikely thatpathogens will enter and grow in sound,intact fruit under actual currentindustry processing practices.

Second, the agency asked theNACMCF about the application andmeasurement of the 5-log pathogenreduction standard to citrus fruit. Inresponse, the NACMCF outlined thefollowing five basic consensus decisionsrelated to the application andmeasurement of the 5-log reductionstandard to citrus juices:

1. The 5-log reduction need not startwith the extracted juice but may beginwith the exterior decontamination ofcitrus fruit. However, processors shouldnot start a cumulative 5-log reductionuntil after the fruit is cleaned (i.e.,washed) and culled (i.e., damaged ordropped fruit is removed so that theremaining fruit is USDA choice level orhigher quality).

2. One possible method to minimizepotential microbial infiltration into thefruit would be by controlling fruit andwash water temperatures, as well asexcluding fruit that is split, punctured,or otherwise not intact. Laboratorystudies indicate that microbialinfiltration of fruit occurred when warmfruit was washed or submerged intocold water (Refs. 13 and 14).

3. The entire 5-log process must occurunder one firm’s control and in oneprocessing facility, i.e., all steps from



fruit receiving to final juice packaging(and all points included in the 5-logreduction process) must occur at onefacility. If processors transport fruit orjuice to another facility for extraction,blending, or final packaging, the 5-logreduction must be accomplished in thesecond facility.

4. If the expressed juice is asepticallypackaged in a single-use sanitary non-reusable tote (sterile bag in box typepackage form) and the bulk packed juicewill be repackaged at another facility, a5-log reduction process must beperformed on that juice prior to final filland packaging. If the juice is useddirectly from the tote (e.g., used todispense juice and juice beverages atretail), the 5-log reduction process neednot be repeated. Because juice in tankertrucks is not juice in a final packageform, juice shipped in bulk tankers mustundergo a 5-log reduction process aftertransport and prior to final fill andpackaging.

5. As part of a HACCP verificationprogram, firms should conductmicrobial testing on the final product ifthe 5-log reduction process relies in parton fruit surface treatment. This testingwould not be batch-by-batch testing forlot acceptance prior to shipping, butwould be used to verify the 5-logreduction process. The testing shoulduse generic E. coli as a means to assessthe control of the process and should beconducted as specified in the HACCPplan, utilizing an appropriate samplingplan. However, if results indicate (i.e.,the presence of generic E. coli) that the5-log reduction has not been achieved,processors should consider testing thejuice for specific pathogens of concern,such as Salmonella or any othermicroorganisms of concern, according toan appropriate sampling plan andprocessors should take suitablecorrective actions. If the 5-log reductionis applied after the juice is expressed,microbiological testing would not berequired as part of a HACCP verificationprogram.

II. Response to the CommentsFDA received approximately 85

responses, each containing one or morecomments, to the notice of intent. FDAaddressed some of these comments inthe juice HACCP proposal. FDAsubsequently received approximately800 responses, each containing one ormore comments, to the juice HACCPproposal. Comments received inresponse to the notice of intent and tothe juice HACCP proposal came fromindustry, trade organizations,consumers, consumer interest groups,academia, and State governmentagencies. Comments concerning labeling

issues are discussed to the extent thatthey fall within the scope of issuespresented by the juice HACCP proposal.Some of the comments supported theproposal. Other comments opposed, orsuggested modifications of variousprovisions of, the proposal. The agencydiscusses below the significantcomments bearing on the proposedHACCP regulation and, whenapplicable, any revisions to theproposed regulation made in responseto these comments. Responses to thenotice of intent that bear on the juiceHACCP proposal and that were notaddressed in that proposal also areaddressed in this document. Forsimplicity, the agency’s discussion doesnot identify comments as to whetherthey were received in response to thenotice of intent or in response to thejuice HACCP proposal.

A. Alternatives to HACCP Considered bythe Agency

In developing a strategy to address thehazards associated with juice, FDAconsidered the following alternatives toHACCP: (1) Increased inspections, (2)current good manufacturing practices(CGMP’s), (3) mandatory pasteurization,(4) labeling as a long-term solution, (5)education, and (6) an approach thatwould draw a distinction betweenuntreated apple cider and all otherjuices. The agency discussed eachalternative in the HACCP proposed rule(63 FR 20450 at 20454) and its reasonsfor proposing the use of HACCP systemsrather than the alternatives (Ref. 2). FDAreceived a number of commentsquestioning the agency’s rejection ofcertain alternatives. The agency’sresponses to those comments are setforth in this section (section II.A). Toprovide a meaningful context for thediscussion of the alternatives, FDA isproviding the following discussion ofHACCP.

HACCP is a focused, efficient,preventive system that minimizes thechance that foods contaminated withhazardous materials or microorganismswill be consumed. The strength ofHACCP lies in its ability to enable theprocessor to identify, systematically andscientifically, the primary food safetyhazards of concern for the specificproducts, the specific processes, and thespecific manufacturing facilities inquestion, and then to implement on afocused, consistent basis, steps (criticalcontrol points (CCP’s)) in foodproduction, processing, or preparationthat are critical to prevent, reduce toacceptable levels, or eliminate hazardsfrom the particular food beingprocessed. Flexibility in how to addressidentified hazards is inherent in HACCP

systems. Even when producingcomparable products, no two processorsuse the same source of incomingmaterials or the same processingtechnique, or manufacture in identicalfacilities. Each of these factors (and theirmany combinations) presents potentialopportunities for contamination of thefood. HACCP focuses the processor onunderstanding his own process and thehazards that may be introduced duringthat process, and identifying specificcontrols to prevent, reduce, or eliminatethe identified hazards.

The flexibility of the HACCPapproach is a critically importantattribute. This flexibility allowsmanufacturers to adjust CCP’s, adjusttechniques used to address CCP’s whenchanges occur in the system (e.g., use ofnew ingredients), and readilyincorporate new scientificdevelopments (e.g., use of new controltechniques, new preventivetechnologies, identification of newhazards). Another important strength ofHACCP is the development of a planwritten by the processor detailing thecontrol measures to be used at CCP’s. Bydeveloping a written plan, juiceprocessors gain a working knowledge oftheir processing system, its effect on thefood, and where in the system potentialcontamination may occur. Both theprocessor and the agency are able toderive the full benefits of a HACCPsystem. The hazard analysis and HACCPplan allow both the processor and theagency to verify and validate theoperation of the system. HACCP’sflexibility also permits processors toselect the appropriate control measuresin the context of how the whole systemfunctions, allowing processors to usethe most appropriate and economicalmethods to control food hazards that arereasonably likely to occur in theiroperation. The ability to choose amongvarious control methods encouragesresearch on and development of newand innovative technologies to betteraddress individual situations. Becauseof its flexibility, HACCP is particularlyadvantageous to small businesses andseasonal processors.

HACCP provides the processor with arecord of identified food hazards. Itallows quick identification of abreakdown in the processing system andthus, prevents products with foodhazards from entering the marketplaceand causing illness. Moreover, review ofrecords over a longer period of time(days or weeks) may reveal a trendtoward a breakdown in the system, suchas a critical processing temperature thatis slowly drifting down. HACCP recordsallow evaluation of whether changes inthe processing system require changes



in CCP’s or their critical limits (CL’s),thus ensuring that the HACCP system isup-to-date and adequate to control allfood hazards that are reasonably likelyto occur. This recordkeeping also allowsregulatory investigators to readilyreview the long term performance of afirm’s processing system, rather thanrelying on a time-limited inspection,which provides only a snapshot of howwell the firm is doing in producing anddistributing safe product on any givenday.

HACCP is ideally suited to respond toemerging problems because a HACCPsystem is a dynamic system that must bevalidated periodically to ensure that allhazards reasonably likely to occur areidentified and controlled via CCP’s.Validation of both the hazard analysisand the HACCP plan entails a thoroughreview to ensure that all hazards that arereasonably likely to occur are addressedin the HACCP system.

Because of its preventive yet flexiblenature, HACCP is recognized by foodsafety professionals as the single mosteffective means to assure the safety offoods. It has been endorsed by theNational Academy of Sciences (Ref. 15),the Codex Alimentarius Commission (aninternational food standard-settingorganization) (Ref. 16), and theNACMCF (Ref. 17). Increasingly, use ofHACCP systems is an indication toimporting countries that food safetysystems that provide a standardizedlevel of public health protection are inplace and being used by producers inexporting countries.

1. Increased Inspection(Comment 1) Several comments

suggested that the increased FDAinspection approach would bepreferable to HACCP.

The agency disagrees. FDA’sresponsibility is to implement andenforce the Federal Food, Drug, andCosmetic Act (the act), i.e., to overseethe manufacture of safe food. Increasedinspection by FDA is a resource-intensive activity that puts theresponsibility and burden for ensuringfood safety on the agency rather than onthe juice processors. Inspections can, ofcourse, provide food processors withvaluable information about improvingthe safety of their products. However,safety cannot be effectively inspectedinto foods. Rather, food processingsystems themselves must be designedand implemented in a manner thatresults in the production of safe food.Part 120 (21 CFR part 120) provides aflexible standard that both the juiceindustry and the agency will use todetermine the adequacy of a process.HACCP has been shown to be an

approach that effectively ensures theproduction of food that is safe andwholesome (Ref. 17). Importantly, theHACCP approach clearly delineates theprocessor’s responsibility to make safeproducts and FDA’s responsibility tomonitor conformance with the actthrough inspections and record review.

(Comment 2) One commentadvocated a short-term solution ofincreased inspections for adherence tosanitation standard operatingprocedures (SSOP’s) and CGMP’s withzero tolerance for noncompliance.Another comment stated that the juiceindustry would welcome increasedinspections as it implements new safetymeasures.

The agency has been activelymonitoring the juice industry, especiallythe fresh juice industry, in response torecent outbreaks. In addition, FDA hasconducted inspections to determinecompliance with the label warningstatement required by § 101.17(g). Theagency will continue this additionaloversight of the juice industry duringimplementation of part 120 until it hasassurance that the industry is incompliance.

(Comment 3) One commentsuggested that cider operations beinspected and graded for cleanliness bythe States, like restaurants.

The agency disagrees with thecomment. Although sanitation (i.e.,cleanliness) is important in cider and allother food production operations, it isonly a starting point for ensuring thatsafe food is produced and distributed toconsumers. This limitation existsregardless of the regulatory agencyinspecting for sanitation.

(Comment 4) Several commentssuggested that industry-fundedinspections could be used to ensure safejuice.

FDA disagrees with these comments.As discussed above, inspections are notan adequate substitute for HACCP.Moreover, the agency does not have theauthority to require or accept fundsfrom the industry for inspections ofjuice processors.

2. Current Good ManufacturingPractices

(Comment 5) Comments maintainedthat a survey of several small citrusproducers and juice bars showed thatSSOP’s and CGMP’s are sufficient toproduce safe juice. One comment statedthat no additional regulations areneeded for dairies that process juicebecause dairies follow sanitation andother procedures outlined by theNational Conference on Interstate MilkShipments (NCIMS) and the application

of these principles affects otherproducts made in these facilities.

The agency disagrees that CGMP’sand SSOP’s alone are adequate tocontrol microbial hazards in juicealthough it does believe that CGMP’splay an important role in juice safety.The survey referenced by the comment,was conducted by the FloridaDepartment of Agriculture & ConsumerServices and found that 17 out of 383samples analyzed (4.4 percent) werepositive for generic E. coli and did notindicate what, if any, othermicroorganisms were present. Whilegeneric E. coli are not pathogens, theirpresence is indicative of fecalcontamination and may be indicative ofthe presence of pathogens such as E. coliO157:H7. (The significance of fecalcontamination is discussed in moredetail in the response to comment 143.)Therefore, it is unclear how thecomments concluded that CGMP’s andSSOP’s provide adequate control ofpotential food hazards to assure thesafety of the food by relying on thesurvey data.

The NCIMS procedures (i.e., thePasteurized Milk Ordinance (PMO)(Ref.18)) were developed to assure thesafety of milk. While there may be somefundamental principles, such as basicsanitation procedures, that apply to boththe production of milk and juice, theproducts are vulnerable to differenthazards. Moreover, States administerthe PMO, and the agency has noinformation indicating consistency inthe application of the PMO to juiceinspections in dairies. Thus,investigators in some States may use thePMO as a guide in conducting dairyjuice operations and others may not.Therefore, the agency does not believethat application of NCIMS procedures insome dairies that process juice negatesthe need for juice-specific HACCPregulations.

(Comment 6) Several commentsargued that the examples ofnonmicrobial hazards (e.g., tin, lead,nitrates, patulin, glass, or plastic) citedin the juice HACCP proposal are CGMPviolations and would not be included ina processor’s HACCP plan.

The agency does not agree with thecomments. Whether or not anonmicrobial food hazard jeopardizesthe safety of a juice product isdetermined by the processor during thehazard analysis of his process. Ifpotential nonmicrobial food hazards arenot reasonably likely to occur, then theHACCP plan does not need to addressthese hazards with CCP’s. Thus, FDAdoes not believe that it is reasonable tomake a global statement that CGMP’s inpart 110 (21 CFR part 110) are adequate



to control nonmicrobial hazards in allsystems, because that determinationmust be made by each individualprocessor through a hazard analysis ofthe individual system.

(Comment 7) Several commentsnoted that the risks posed by thenonmicrobial hazards identified by FDAcannot be quantified for economicpurposes, that microbial hazards aloneare not an adequate basis on which tomandate HACCP, and that CGMP’s areadequate.

FDA disagrees with these comments.There are nonmicrobial food hazardsthat may be reasonably likely to occurin juice. Some non-microbial hazards,such as glass, tin, and copper, presentacute risks (Ref. 6), and result in acuteillnesses or injuries that generatemedical and hospital costs, as well aslost productivity costs.

The adverse health effects of othernonmicrobial hazards are chronic (long-term) in nature. For example, long-termexposure to the mycotoxin, patulin, hasbeen shown to be toxic in safetyassessments conducted in the UnitedStates (Refs. 19 and 20) and byinternational organizations (Refs. 21 and22). Patulin is produced by severalspecies of mold that can grow on apples,particularly if bruised or otherwisedamaged, and has been found to occurat high levels in some apple juiceproducts. The long-term toxic effects inyoung children are of particular concernbecause children consume largerquantities of apple juice relative to bodyweight than other age groups. Acompilation of data from three surveysshowed that nearly one-fifth of thesamples of apple juice contained levelsof patulin in excess of 50 microgram/liter (µg/L) (Ref. 23), the level recentlyestablished by FDA in draft guidance asthe maximum level that should bepresent in foods (Ref. 24).

The agency recognizes thatquantifying the economic effects ofchronic non-microbial hazards isdifficult. Given the difficulties inquantification, FDA chose to notinclude nonmicrobial hazards withchronic health risks in the PRIA,thereby underestimating the benefits ofthe proposal. Nevertheless, hazards withchronic health risks exist and thepotential effects on health are real.Thus, hazards with chronic health risksmust be considered, along withnonmicrobial hazards with acute healthconsequences and microbial hazards,during the hazard analysis and adetermination made as to whether thepotential hazard is reasonably likely tooccur (comment 63 discusses how ahazard analysis must be conducted) and

thus, must be included in the HACCPplan.

(Comment 8) Several commentsmaintained that the enforcement ofCGMP’s or sanitation standards wouldensure the safety of all juices.

The agency disagrees with thecomments. Outbreaks of foodbornedisease have been associated with juicedespite the fact that the processorsappear to have been activelyimplementing CGMP’s. Increasedcompliance with the CGMP regulationsin part 110, including all sanitationprovisions, is certainly desirable.However, CGMP’s are general in natureand apply to all types of facilities thatprocess all types of food products fromhighly processed foods to raw foods thatare merely packaged and labeled.CGMP’s were not designed specificallyto address individual productionfacilities (for juice or any othercommodity) or the unique attributesassociated with specific foodbornehazards. HACCP systems, as discussedin section II.A of this document, providefocused, product- and process-specificprevention and control of potentialhazards. HACCP augments the controlsestablished through CGMP’s by: (1)Determining the food hazards that arereasonably likely to occur in a specificfacility and process and thus, warrantextra consideration beyond applicationof routine food safety measures, (2)identifying a specific CGMP oradditional control measure that must beundertaken to prevent this food hazardthat is reasonably likely to occur fromreaching the consumer, and (3)developing a verifiable procedure forassuring that each control measure wasapplied and was effective. This focusedconsideration of hazards and theirprevention provides a higher degree ofsafety assurance than application ofCGMP’s.

3. Mandatory Pasteurization(Comment 9) Several comments

requested that the agency mandatepasteurization or use of a universalthermal process (thermal kill) to ensurejuice safety. The comments maintainedthat mandatory pasteurization is areasonable, science-based solution thatwould ensure safe juice, is consistentwith FDA’s mission to protect thepublic health, and would assureconsumers and regulators that themicrobial hazards associated with juiceare being prevented in the most effectivemanner. Conversely, a number ofcomments opposed mandatorypasteurization. They argued thatnutritional value is lost from heattreatment; some consumers preferunpasteurized juice; pasteurized juice

may become contaminated aftertreatment and still put consumers atrisk; and the apple cider and fresh juiceindustry would be destroyed.

Based upon the available information,FDA does not believe that it is necessaryor appropriate to mandatepasteurization or other thermaltreatment of juice. The agency is awareof the reasons why processorspasteurize or elect not to pasteurizetheir juice products. Pasteurization, aheat treatment sufficient to destroypathogens, is an effective and proventechnology that will attain the 5-logreduction in pathogens and, thus ensuremicrobiologically safe juice.Pasteurization also results in a longershelf-life of refrigerated juices. Withproper post-processing handling,pasteurization assures consumers andregulators that the potential microbialhazards associated with juice areprevented. However, pasteurization isnot the only method for addressingpotential microbial contamination. Thiswas discussed extensively in the juiceHACCP proposal (63 FR 20450 at 20454)(Ref. 2) and again in the juice labelingfinal rule (63 FR 37030 at 37041) (Ref.5). This approach is supported by theNACMCF recommendation that FDAestablish safety performance criteria forappropriate target organisms rather thanmandating a specific interventiontechnology (Ref. 25). Mandating aspecific intervention technology such aspasteurization would limit thedevelopment of new, potentially lesscostly technologies that may be aseffective as pasteurization. Newnonthermal technologies (e.g., UVirradiation and pulsed light, asapproved by FDA; high pressure) maybe able to achieve the required pathogenreduction. The use of non-thermaltechnologies will provide consumerswith a greater selection of safe productsto purchase. Furthermore, mandatorypasteurization would not control non-microbial hazards in juice. Therefore,FDA is declining to mandatepasteurization for juice.

(Comment 10) One comment statedthat pasteurization should be mandatoryfor apple cider to eliminate a majorsource of health risks.

FDA disagrees with the comment.Under § 120.24, apple cider processorsmust treat their juice to achieve a 5-logreduction in the pertinent pathogen. Atthe present time, the agency is notaware of any technology that canaccomplish the 5-log reduction in applejuice products except by treating theextracted juice with a ‘‘kill step.’’However the ‘‘kill step’’ does notnecessarily have to be pasteurization.This approach allows for innovation in



the development of new processes toachieve the 5-log pathogen reduction.

4. Labeling(Comment 11) Two comments

suggested that FDA require eitherpasteurization or a permanent warninglabel statement for producers who donot pasteurize. One comment stated thatFDA should require HACCP with a CCPof either a 5-log performance standardfor pathogen reduction or a warninglabel.

FDA disagrees with the comments.Under § 120.24, juice processors mustachieve the 5-log reduction in theirjuice. As discussed in both the HACCPproposal and in this final rule, it ispossible for firms to manufacture juiceto achieve this reduction by means otherthan pasteurization. The alternativepresented in the comments, labeling,has some limitations as a public healthmeasure. The effectiveness of labelinguntreated juice to alert consumers topossible harmful effects from itsconsumption relies on consumers’reading, comprehending, and acting onthe information in the labeling.Although labeling can provideconsumers with the information to makefood safety related choices, education isan important factor in a consumer’schoice. Therefore, there are limitationsto the effectiveness of labeling.

The agency mandated the use ofwarning label statements on juicelargely as an interim step to establishingthe HACCP regulation. For most juiceproducts, the warning label is a shortterm solution. While FDA is reluctant torely on labeling as the sole safetymeasure, the agency recognizes that incertain circumstances, labeling may, onbalance, provide the most reasonableapproach to protect the public health.FDA believes that HAACP, as requiredin this final rule, is a reasonableapproach because, in contrast to someother food safety problems, the factsshow that, for juice, processor control ofpathogens is reasonably achievable.Moreover, a warning label does notsubstitute for adequate processing ofjuice, is not an appropriate substitute forthe 5-log performance standard, andwould not be considered a CCP for juiceunder part 120.

For juice produced by retailers (asdefined in the rule), however, thewarning statement is a long termsolution. The agency discussed itsreasons for exempting retailestablishments from part 120 in thejuice HACCP proposal (63 FR 20450 at20464) (Ref. 2), and these reasons arefurther discussed in section III.B.2.b ofthis document. The agency intends towork closely with the States to provide

recommendations for implementingmeasures that will assure safe juice atretail. Therefore, the agency concludesthat its current regulations andprograms are balanced and appropriatefor juice and juice products.

(Comment 12) Several commentsasked that FDA make the warning labelstatement a permanent option because,if it is adequate to ensure consumersafety with products exempt fromHACCP, it should be adequate for alljuice products.

FDA disagrees with the comments. Asnoted in the previous response, whilethe warning label statement may beeffective, particularly with consumersaware of juice safety problems, it haslimitations as a public health measure.The warning label statement simplyinforms consumers that the juicebearing the statement has not beentreated to control pathogens and that theconsumption of untreated juice maypose a risk of illness. As noted, theeffectiveness of any warning label relieson consumer education and action. FDAis not changing the warning labelstatement requirements in thisrulemaking.

5. Education(Comment 13) Several comments

maintained that increasing industryeducation is all that is needed to ensurethe safety of all juices.

The agency disagrees. While FDAsupports and encourages processoreducation as a way to improve the safetyof the food supply, such measuresalone, without being teamed withimplementation of an effective foodsafety control program, such as HACCP,and government oversight, will notensure consumer protection fromhazards that may be present in juice.Training and education is only one stepin the effective implementation of anyfood safety system, including HACCP.Effectively, this final rule requires theindustry to improve their education infood safety in order to implementeffective HACCP systems.Implementation of an effective HACCPsystem demonstrates a processor’sunderstanding of HACCP principles andthe ability to translate theory intoproduction of safer food. Therefore, theagency concludes that increasedindustry education alone would not besufficient to ensure the safety of alljuices.

6. Alternative Approach(Comment 14) Many comments

supported the alternative approachoutlined in the proposed rule (63 FR20450 at 20456) (Ref. 2) that would: (1)Require producers of apple cider to

choose between HACCP with aperformance standard and labeling and(2) require processors of all other juicesto choose between HACCP, aperformance standard, and labeling.

The agency has evaluated thealternative approaches and concludesthat HACCP with a performancestandard is the most effective andefficient approach to ensure safe juice.FDA notes that no data or otherinformation were submitted to persuadethe agency that the alternative approachdescribed in the proposal wouldprovide adequate public healthassurance as would be provided by theHACCP regulation set forth below.Although more outbreaks have beentraced to the consumption of apple juicethan other juices, a fact reflected in theproposed alternative approach, theagency concludes that, becausemicrobial, chemical, and physicalhazards may occur in all juices, andoutbreaks have been associated with avariety of juices, there is a need toregulate all juices in the same generalmanner. Furthermore, the performancestandard and the label warningstatement only address microbialhazards. In contrast, HACCP systemsaddress physical and chemical, as wellas microbiological, hazards, thusproviding greater assurance that juice issafe. Therefore, the agency is requiringthat all juice processors with theexception of those specificallyexempted by § 120.3(j)(2) use HACCPsystems as set forth in part 120.

B. Response to the Decision to ProposeHACCP

FDA proposed to require HACCP forjuice products because it had tentativelyconcluded that HACCP was anappropriate system of preventivecontrols necessary to produce safe juiceproducts. The evidence presented in theproposal demonstrated that juice hasbeen a vehicle for pathogens that havecaused a number of foodborne illnessoutbreaks. While pathogens can becontrolled through heat treatment, thedata (Ref. 2) clearly demonstrate thatthere are potential nonmicrobiologicalhazards associated with juice thatcannot be controlled through heattreatment. For these reasons, FDAtentatively concluded that a HACCPprogram that addresses all potentialhazards (i.e., microbiological, chemical,and physical), allows each juicemanufacturer to evaluate its ownprocess, and to institute appropriatecontrols for all hazards identified asreasonably likely to occur in thatmanufacturer’s process should beestablished.



(Comment 15) Several commentsadvocated HACCP limited to pathogencontrol.

The agency disagrees with thecomments. While pathogen control is asignificant part of any HACCP systemfor juice, there are potential chemicaland physical hazards that can occur injuice, with significant public healthimplications, and these hazards may bemost effectively controlled throughapplication of HACCP (Ref. 2). HACCPprovides a way to focus on specificCCP’s addressing specific hazards, bothmicrobial and non-microbial (e.g., tin,lead, nitrates, patulin, glass, or plastic)that are relevant to juice processingoperations and products. These hazardsmay be appropriately identified in thehazard analysis as hazards that arereasonably likely to occur andcontrolled through a HACCP plan.

There are a number of potentialhazards for juice that are nonmicrobialin nature. For example, juice productshave become contaminated withcleaning solution. If this contaminationis a hazard that is reasonably likely tooccur in a particular process (e.g., thereis a repeated history of its occurrence),the processor must establish controls inits HACCP plan to prevent thecontamination rather than address thecontamination in their SSOP’s.

Similarly, some juice products havebeen recalled due to the presence ofglass. Glass shards in juice represent asevere and acute public health threat.Processors who package in glass mustconsider whether glass in their finalproduct is reasonably likely to occur inthe absence of control. If so, processorsmust establish controls for glass in theirHACCP plans.

Excess detinning represents anotherpotential nonmicrobial hazard for juice.Certain juices are purposely packaged toallow some detinning of the can in orderto protect the color quality of theproduct. However, detinning can beaccelerated by unusually high nitratecontent in the product or by elevatedtemperatures during storage or shipping(Refs. 26). Excessive detinning hasresulted in consumer illness (Refs. 26and 27). Thus, processors of juiceproducts that employ detinning as ameans of color protection mustdetermine whether it is necessary toestablish specific control measures, i.e.,a CCP, because excessive detinning isreasonably likely to occur.

Potential hazards may also be causedby the nature of incoming materials.Patulin in apple juice products is onesuch example. Patulin is a mycotoxinproduced by several species of moldthat can grow on apples, particularly ifbruised or otherwise damaged. A

compilation of data from three surveysshowed that 19 percent of samples ofapple juice contained levels of patulinin excess of 50 µg/L (Ref. 23). FDA hasrecently issued guidance describing 50parts per billion (ppb) as arecommended level for patulin (Refs. 19and 24). For apple juice processors,patulin may represent a hazard that isreasonably likely to occur when juice ismade from bruised or damaged fruit, aseven moderate bruising can result inmold growth on apples. Moreover,patulin may be a chronic potentialhazard and therefore particular attentionmust be given to the frequency ofoccurrence. Therefore, a prudentprocessor must determine whether thefrequency of occurrence of this potentialhazard in juice is unacceptable withoutcontrols. If patulin is reasonably likelyto occur at unacceptably high levels,processors must include it as a hazardin their HACCP plans. Patulin is not thesole mycotoxin that may be a hazard injuice. There is evidence that othermycotoxins, such as ochratoxin ingrapes and Alternaria toxins in fruit andvegetable products (Ref. 28), may beemerging public health problems injuices and at least warrant monitoring offuture developments.

Lead contamination has also beenassociated with juices. In 1996, infantapple prune and prune juices wererecalled for unacceptable levels of lead(Refs. 29 and 30). More recently,unacceptable levels of lead have beenfound in babyfood containing carrotsand in carrots in frozen mixedvegetables as a result of leadcontamination in the soil (Refs. 31 and32). Juice made from produce with highlead levels will also be high in lead. AGerman survey of lead in foods foundthat 12 percent of fruit juices containedelevated levels of lead and over 5percent of fruits had elevated levels oflead (Ref. 33). It is well recognized thatlead has no known ‘‘no-effect level’’ andconsumption of lead-contaminated foodis a recognized health problem,particularly for children in theirdevelopmental stages. Responsibleprocessors should exercise control toensure that their juice products do notcontain lead at harmful levels. Again,HACCP provides both the necessarycontrol and flexibility to address theproblem of lead contamination. If aprocessor is importing juice from ageographic region known to have aproblem with lead contamination infoods, that processor should identifylead as a hazard in their HACCP plan.However, if a juice processor determinesthrough its hazard analysis that, giventheir source, incoming materials are not

reasonably likely to be contaminatedwith lead, that processor would notneed to identify lead as a hazard in itsHACCP plan. Importantly, processorswho are currently implementing HACCPto address microbial hazards onlyalready have the infrastructure in placeto analyze their processing system andcan then determine if there are chemicalor physical hazards that are reasonablylikely to occur. Therefore, with minimaleffort, these processors can readilyexpand the scope of their HACCPsystem to include consideration of allpotential hazards.

Based upon the foregoing, the agencyconcludes that chemical and physicalhazards, as well as pathogens, may posepublic health risks in juice products.These hazards, when they arereasonably likely to occur, requirespecific preventive controls. HACCP isthe most appropriate system to controlboth microbial and nonmicrobialhazards that are reasonably likely tooccur in juice products.

(Comment 16) Several commentssuggested that quality assurance systemsdevised specifically for juices would beappropriate alternatives to mandatoryHACCP with a performance standard.The comments contended that thequality assurance systems developed byand for the citrus industry inconjunction with the University ofFlorida (Ref. 34) are adequate to ensurethe safety of citrus juices and that theApple Hill Quality Assurance Program(Ref. 35) is adequate to ensure the safetyof apple juice. Some comments assertedthat these programs are just as effectiveas HACCP, while being less expensiveto implement.

FDA encourages the efforts byindustry, universities, State and localgovernment agencies, and others todevelop programs to ensure the safetyand quality of the food supply and isaware of several such programs. Theagency has reviewed the qualityassurance programs mentioned by thecomments and finds that the HACCPsystem in part 120 provides a greaterlevel of public health assurance. If aprocessor can implement a qualityassurance program that also meets therequirements of part 120, then FDA doesnot object to the processor using thatprogram for its HACCP system.However, quality and safety are notnecessarily synonymous. Qualityprograms focus on the combination ofattributes or characteristics of a productthat have significance in determiningthe degree of acceptability of thatproduct by consumers. Safety programsfocus on hazards and public healthassurance. Quality assurance systemsmay not address all public health



3 FDA has not defined what pasteurization meansin terms of juice and juice products because of theunique characteristics of the many various types ofjuice and juice products. The scientific literatureprovides data on adequate pasteurization times andtemperatures. Prudent processors usingpasteurization rely on this research data for theirparticular types of juices.

hazards just as safety programs may notaddress all quality issues.

(Comment 17) Several commentsrequested that FDA exempt from theHACCP regulation processors whopasteurize their product, make shelf-stable product, or meet the 5-logperformance standard because the aimof the rule should be pathogen control.The comments said that HACCP isregulatory overkill and it is unfair toimpose HACCP on the 98 percent whopasteurize in order to control the realrisk from the 2 percent who do not. Thecomments noted that illness outbreakevidence only supports the need forinterventions to control pathogens inunpasteurized juice because there havebeen no reported outbreaks of illnessfrom consumption of pasteurized juice.

The agency agrees that, when usedwith appropriate times andtemperatures, thermal pasteurization 3 isa proven and effective method forcontrolling pathogens. However, theeffectiveness of pasteurization isdependent on implementation of anintegrated system that validates andverifies the efficacy of the pasteurizationprocess. It is likely that processors whomake concentrated, shelf-stable, orpasteurized juices have alreadyincorporated HACCP principles, aimedat control of pathogens, into theirprocessing operations (Ref. 36).Processors already attaining the 5-logreduction performance standard arelikely to have established processparameters (i.e., critical limits), aremonitoring the process, and are keepingrecords of their monitoring. Therefore, itshould require minimal effort forprocessors that make concentrated,shelf-stable, or pasteurized juices tosatisfy the requirements of part 120relating to pathogen control. Moreover,as discussed in section L of thisdocument ‘‘Process Controls,’’ inrecognition of the effectiveness ofthermal treatments for pathogen control,FDA is providing in part 120 analternative method for processorsmaking shelf-stable juices or certainjuice concentrates to comply with the 5-log reduction in the pertinent pathogen.The agency believes that the alternativemethod is reasonable because theprocesses for shelf-stable juices andconcentrates are so rigorous that theyexceed the minimum requirements forcontrol of microbiological hazards. A

copy of the thermal process in aprocessor’s hazard analysis will provideevidence that the process is adequate.

Importantly, pathogen control is notthe only problem with juice safety. Asdiscussed in the juice HACCP proposal(63 FR 20450 at 20451) (Ref. 2) and inthe response to comment 15, there arealso established chemical and physicalrisks with juice. A juice product canonly be considered safe if all hazards(i.e., microbial, chemical, and physical)are considered and, if these hazards arereasonably likely to occur, arecontrolled. Therefore, FDA concludesthat processors of thermally processedjuice must comply completely with thisHACCP regulation, but can do so withminimal added effort.

(Comment 18) Some commentscontended that the HACCP proposalgoes way beyond establishing necessarymeasures to ensure juice safety and isneither reasonable nor economicallyfeasible for an industry characterized bysmall producers, family businesses,seasonal production, and very littleprior experience in food safetymanagement. Comments also noted thatthere is a low level of compliance withseafood HACCP among small producersand the success of juice HACCP willdepend upon small processorscomplying with costly regulations.Conversely, several comments arguedthat HACCP is the appropriate foodsafety system for small producersbecause it can be implemented withoutbeing overly burdensome and forcingthem out of business.

The flexibility of HACCP allows theprocessor to control hazards identifiedin the hazard analysis in a manner thatbest fits an individual operation, largeor small. In addition, if small producersactually have very little prior experienceor knowledge in food safetymanagement, as some commentsasserted, then HACCP training andconsultation are very much needed bythis group and will provide specificfood safety goals customized to theirindividual operations.

Thus, features of the agency’sregulatory strategy will accommodatesmall processors. First, FDA intends toprovide a juice HACCP hazards andcontrols guidance that will assistprocessors. Second, this final rule has astaggered compliance schedule(§ 120.1(b)(1) and (b)(2)), whichprovides small and very small juiceprocessors additional time to implementfully the final rule.

The agency’s HACCP strategy for theseafood industry, which is dominatedby small processors, has been toacknowledge that the implementation ofHACCP can be an educational process,

especially with regard to science-basedanalysis, and thus to allow for theprogression in mastering the HACCPsystem that accompanies that process.The progress in implementing HACCPsystems that the seafood industry ismaking suggests that other segments ofthe food industry, including thosepopulated by small businesses, can alsobenefit from a HACCP program, even ifcomplete understanding of whatconstitutes full implementation of aHACCP system is not immediate.

(Comment 19) Several commentsstated that HACCP presents an undueburden to the pasteurized juice industrywith no consumer benefits. Thecomments stated that the chemicalhazards cited by FDA are not reasonablylikely to occur and that there has neverbeen a foodborne illness outbreakassociated with pasteurized juice.

The agency does not agree. Thepreamble to the proposed rule describedincidents of illness associated withchemical contaminants in juice (63 FR20450 at 20451) (Ref. 2). Chemicalhazards can occur in juice regardless ofpasteurization. Moreover, for somejuices, the risk of chemicalcontamination can be high, dependingon the quality of the incoming produceand the chosen processing steps. In fact,in two recent incidents, juice wasrecalled by the processor in one casedue to the presence of dairy and eggallergens (Refs. 37 and 38), and in theother, due to the presence of cleaningsolution (Refs. 39, 40, and 41). Asdiscussed earlier in comment 15, therisk of patulin contamination in applejuice is high if the processor usesbruised apples.

The agency does not agree thatHACCP for the pasteurized juiceindustry does not convey benefits toconsumers. While the classic definitionof pasteurization is a heat-treatment todestroy pathogens, the agency has noassurance that all juice processors whobelieve they are pasteurizing theirproducts actually have all the controlsin place to assure that every particle ofthe juice is receiving sufficient heat todestroy pathogens. Moreover,pasteurization alone does not assure thesafety of juice products. Proper handlingof the product after pasteurization isrequired to prevent post-processcontamination. A HACCP system basedon CGMP’s provides assurance to theprocessor, as well as to the agency andthe consumer, that pasteurized productsare safe.

The agency is required, by ExecutiveOrder and law, to consider both thecosts and benefits to consumers andindustry. This analysis can be found inthe PRIA, and the Regulatory Flexibility



Analysis in sections V and VI of thisfinal rule. Based on FDA’s analysis, thebenefits (i.e., prevention of illness) ofthis final rule outweigh the costs toindustry.

A few comments expressed concernthat HACCP regulations may beenforced at the expense of CGMP’s.

The agency does not agree with thecomments. In fact, FDA expects that theopposite will be true. A HACCP systemcannot be operating properly if aprocessor is not following CGMP’sbecause CGMP’s provide the foundationfor an adequate and appropriate HACCPsystem. Therefore, to evaluate theeffectiveness of a HACCP system,processors and agency inspectors mustalso evaluate processors’ adherence toCGMP’s.

(Comment 20) One comment statedthat HACCP as set forth in the proposalplaces the responsibility for productsafety on the government rather than theprocessor.

FDA does not agree with thiscomment. Each juice processor isresponsible for developing a system ofpreventive controls by adapting theHACCP principles in new part 120 to itsspecific operation and needs. UnderHACCP, the manufacturer is responsiblefor knowing and understanding itsmanufacturing process, identifyingpoints where contamination can occur,and implementing control measures inorder to produce safe food. Toaccomplish this, the processor must: (1)Have an individual who is trained inHACCP conduct a hazard analysis,determine where controls are needed,and validate the adequacy of anyHACCP plan that is developed; (2) putthose controls in place and verify thatthey are working through monitoringand recordkeeping; and (3) revalidatethe HACCP plan at least annually or anytime there is a significant change in theprocess or whenever scientificinformation demonstrates a new riskthat processors have not previouslyconsidered in their hazard analysis.FDA’s responsibility is to conductoversight to ensure that HACCP isproperly implemented and is effective.

(Comment 21) Several commentsstated that HACCP’s cost is not justifiedbecause most foodborne illness occursas a result of problems that originateafter juice leaves the processor andHACCP will not remedy these problems.One comment cited a source thatestimated that food manufacturers areinvolved in less than 10 percent offoodborne disease outbreaks of knownorigin (Ref. 42).

FDA maintains that all steps in juiceproduction and handling are potentialpoints of contamination in the absence

of adequate controls, not just post-process handling. Processors mustconsider prevention of post-processcontamination to the extent feasible. Forexample, post-process piping mustprevent contamination from occurringprior to packaging. HACCP systems areimplemented to assure the safety of foodwhen it leaves the processor’s controland under normal handling conditionsafter that. The agency points out that theCAST report cited by the commentincludes all foods (not just juice) and allfood sources (processors, food service,institutions) and is limited to microbialcontamination of foods. The majority ofjuice outbreaks have not been caused bypost-process contamination but ratherby contaminated incoming product orcontamination during processing (Ref.43). Thus, the performance standard (5-log reduction in pathogen level)established by this rulemaking is set toensure that the final product is notcontaminated with illness-causingbacteria that may have been present onincoming fruit. In addition, processorsmust use CGMP’s, SSOP’s, and HACCPto ensure that product is notcontaminated with pathogens while inthe processing facility.

(Comment 22) Several commentsstated that hazards in juice areadequately dealt with under State laws(i.e., Connecticut, Florida, Illinois,Maryland, Massachusetts, Michigan,New Jersey, New Hampshire,Wisconsin).

The agency applauds State efforts toensure the safety of juice produced andsold in their States. However, whilethere may be some State laws thatgovern the manufacture of juices, theselaws are generally not as comprehensiveas this HACCP rule. In addition, not alljuice producing States have applicableState laws. This HACCP final ruleprovides a uniform minimum level ofpublic health protection across thecountry for juices. FDA believes thatthis final rule will enhance State effortsand help extend the food safety effortsof some States to all States.

C. Significance of Illness DataThe preamble to the proposed

regulation described occurrences ofjuice-related foodborne illness in theUnited States. It is well recognized thatfoodborne illnesses are significantlyunderreported to public healthauthorities (Ref. 44). Consequently,precise data on the numbers and causesof foodborne illness do not exist. Theprimary purpose of these regulations isto ensure that juice is safe through theuse of preventive controls that aresystematically and routinely applied injuice processing, and applied in a way

that can be verified as effective bycompany management as well asregulatory authorities.

(Comment 23) Many commentsquestioned the validity of FDA’s riskassessment on juice. They stated that itwas not scientific and sound, notprobabilistic, didn’t include pasteurizedjuice, and contains inaccuracies.However, comments did not specificallyidentify the inaccuracies.

FDA maintains that its ‘‘PreliminaryInvestigation into the Morbidity andMortality Associated with theConsumption of Fruit and VegetableJuices’’ is sound. As outlined in thejuice labeling final rule (63 FR 37030 at37031) (Ref. 5), the agency performed adetailed evaluation of the potentialhazards posed by untreated juices. Thisevaluation is part of the record of theHACCP proposal and was included asan appendix to the PRIA (63 FR 24292;May 1, 1998) (Ref. 6). The evaluationwas based on available scientificinformation, included pasteurized juice,and examined both heat-treatablemicrobial hazards and non-heat-treatable hazards. Non-heat-treatablehazards are discussed in section VII andthe evidence is summarized in table 7of FDA’s Investigation. The conclusionthat the most significant juice-bornehazards are associated with non-heat-treated juice was based on thisinvestigation.

(Comment 24) One comment statedthat all outbreaks in cider have beentraced to using dropped apples orunsanitary processing conditions andthat eliminating these circumstanceswill stop outbreaks in cider.

FDA disagrees with the commentbecause the causes of cider-relatedoutbreaks are not limited to using dropsor processing in an insanitary facility. Infact, from a structural standpoint, applesare susceptible to contaminationbecause they have an open blossom end,and thus, the interior of the fruit can becontaminated while the exterior appearsclean and blemish free (Ref. 45). Thispotential for contamination is confirmedby data that show that cider, even whenit is made from tree-picked fruit andprocessed under CGMP’s, can containpathogens and provide an environmentconducive to the survival of pathogensof public health significance (Ref. 13).

(Comment 25) Several commentsmaintained that the risk from juice islow and does not warrant a HACCPregulation.

The agency does not agree with thecomments. There are documented casesof lifethreatening foodborne illnessassociated with the consumption ofvarious juice products contaminatedwith pathogens such as E. coli O157:H7,



Salmonella species, Cryptosporidium,and Vibrio cholerae. Some of theillnesses associated with juices havebeen very severe (e.g., cases of long-termreactive arthritis and severe chronicillness) (Ref. 2). In one case,consumption of contaminated juiceresulted in the death of a child and inanother case, consumption ofcontaminated juice contributed to thedeath of an elderly man. These reportedoutbreaks likely represent only afraction of the outbreaks and sporadiccases that actually occur (Ref. 44).

Chemical and physical hazards havealso been associated with juices.Examples of these hazards wereincluded in the proposal (63 FR 20450at 20451) (Ref. 2) and are discussed indetail in the response to comment 15.

The evidence demonstrates thathazards can be present in juice. Thecomments did not provide the agencywith additional data that eithercontradict FDA’s hazard evaluation (Ref.6) or that can be used to reevaluate thehealth risks associated withconsumption of juice products.Therefore, FDA believes that the publichealth risk associated with consumptionof juices is sufficiently high to justifymandating use of HACCP systems.

(Comment 26) Many commentsargued that HACCP is no longernecessary for juice because of the safetyimprovements made by the juiceindustry since the 1996 outbreak of E.coli O157:H7 in apple juice. They statedthat these improvements are evidencedby the fact that there has not been anoutbreak associated with juice since1997.

FDA disagrees with the comments.There have been documented outbreaksof juice-associated foodborne illnesssince 1997. The agency acknowledgesthe recent steps taken by the industry toaddress microbial contamination ofjuice. Nevertheless, while there were noreported outbreaks attributed to juice inthe United States in 1997 and 1998,there were several outbreaks in 1999and 2000. These outbreaks are discussedbelow.

In early 1999 in south Florida, therewere 16 reported cases from Salmonellatyphi linked to the consumption offrozen mamey, a product often used tomake juice beverages (Ref. 46).

During June 1999, there was anoutbreak of Salmonella serotypeMuenchen infection associated withconsumption of unpasteurized orangejuice (Ref. 47). As of April 2000, a totalof 423 cases, including one thatcontributed to a death, from S.Muenchen infection had been reported.Nine additional Salmonella serotypes

were identified from orange juicecollected from the implicated firm.

In October 1999, there was anoutbreak of E. coli O157:H7 incommercially-processed unpasteurizedapple cider in Oklahoma with 9illnesses (7 children) and 6hospitalizations (4 cases of hemolyticuremic syndrome (HUS)) (Ref. 48).

While no illnesses were reported inOctober 1998, the State of Florida foundSalmonella Manhattan in anunpasteurized juice blend containingstrawberry, apple, and papaya juice(Ref. 49).

In November 1999, the same firminvolved in the June 1999 outbreakinitiated and subsequently expanded arecall because their routine testingfound Salmonella in samples ofunpasteurized orange juice (Ref. 50).The product had been distributed torestaurants and other food serviceestablishments in eight U.S. States andone Canadian Province and to one retailstore in Oregon. No known illnesseswere associated with this incident.

In April 2000, there was an outbreakof Salmonella Enteritidis associatedwith unpasteurized orange juice (Ref.51). As of May 2000, 143 cases tracedto this orange juice had been identifiedin Arizona, California, Colorado,Minnesota, Nevada, Washington, andWyoming.

Also in April 2000, 24 people whoattended a conference in Atlanta,Georgia, were reported ill with viralgastroenteritis (Ref. 52). Fresh-squeezedunpasteurized fruit smoothies wereimplicated in this outbreak. CDCdetected Norwalk-like virus in threepatient stools.

Thus, the potential for juice-relatedillness still exists, although the numberof illness outbreaks linked to juice mayvary from year to year. In addition, theagency has no information indicatingthat all members of the juice industryhave implemented adequate safetyimprovements to address the potentialfor microbial contamination and otherpotential hazards in their products. Thefact that outbreaks continue to occur isevidence to the contrary.

(Comment 27) One commentasserted that most problems associatedwith citrus juices were a result ofinsanitary processing conditions atsmall or very small businesses orcontamination by asymptomatic foodhandlers, and HACCP would notprevent problems in either situation.

The agency disagrees with thiscomment. FDA often finds in theirinvestigations into outbreaks that theexact cause of the outbreak is unknown.The agency may find various possiblecauses that include those mentioned by

the comment. However, as discussedthroughout this preamble, insanitaryconditions and workers’ health are notthe only source of food hazards in juice.For example, if juice is made fromcontaminated fruit and the 5-logreduction is not accomplished, anoutbreak could occur. HACCP systemsdo provide greater assurance thanCGMP’s and SSOP’s alone that juice issafe. HACCP recordkeeping provisionsallow processors and regulators todetect process deviations and stopdistribution of or recall product beforeit results in an outbreak.

(Comment 28) Several commentsstated that the rules should cover appleproducts only, asserting this is whereproblems have occurred.

The agency disagrees that only applejuice should be covered by part 120, andall other juices should be exempt. Therehave been illness outbreaks from othertypes of juice, e.g., orange juice. Someof these were cited in the proposal (63FR 20450) (Ref. 2). As discussed incomment 27, additional outbreaks sincepublication of the proposal haveoccurred. Therefore, FDA concludesthat because there are documentedfoodborne illness risks associated withjuices other than apple juice, all typesof juice must be covered under part 120.

(Comment 29) Many commentsargued that juice regulations should notbe more stringent than regulations forother foods that are more hazardous,such as seafood or meat and poultry.Many comments noted that seafoodHACCP has no performance standardbut is a much higher risk food thanjuice.

The agency disagrees that juice isbeing regulated more stringently thanwarranted. HACCP for juice mirrorsFDA’s HACCP regulations for seafoodand USDA’s regulations for meat andpoultry. In contrast to most seafood andmeat and poultry, juice is generallyconsumed as sold. The record of thisproceeding demonstrates that microbialcontamination of juice is a substantialpublic health risk and that aperformance standard is achievable as apractical matter. Thus, to ensure thesafety of juice products, FDA isestablishing a mandatory HACCPprogram that includes a performancestandard to prevent, reduce, oreliminate levels of pathogens known tocause foodborne illness. Theperformance standard ensures thatcontrols within the HACCP system areworking effectively to reduce the risk ofillness and that the final product is safe.

(Comment 30) One commentmaintained that the physical hazardsrelated to juice are a result of metal cans



and glass, both of which are not used bythe fresh juice industry.

FDA recognizes that juices that areminimally processed usually arepackaged in plastic to provide forexpansion of the product. Whether ornot packaging materials are included ina processor’s HACCP plan will bedetermined in the processor’s hazardanalysis. If the hazard analysis showsthat a particular operation has nophysical hazards, such as metal or glass,that are reasonably likely to occur, nocontrol measures are required for suchhazards. Even if there are no physicalhazards in fresh juice that requirecontrols, the risk of microbialcontamination of fresh juice is well-documented and a HACCP approach isneeded to address these risks.

(Comment 31) One comment statedthat the Bacillus cereus incident citedby FDA is not significant and any finalrule should clearly state thatsporeformers are not a problem thatneeds to be considered in a treatmentsystem for juice.

The agency has considered the issuessurrounding hazards from spore formingbacteria. Regulations in parts 113 and114 (21 CFR parts 113 and 114) alreadyaddress the hazard from Clostridiumbotulinum in low acid canned foods andacidified foods. Spore forming bacteriahave not been associated with publichealth problems in juice that has beenproperly handled (e.g., refrigerated) afterleaving the processing plant. Therefore,FDA does not anticipate that processors’hazard analyses will establish that sporeforming bacteria are a hazard that isreasonably likely to occur.

D. Comparison of the Proposal and ThisFinal Regulation

The comments received generatedsome clarifications of and changes inprovisions of the proposed regulation.These are discussed in detail in thecomments noted after each item. Amongthe most significant clarifications andchanges are the following:

• Clarification that the regulationcovers intrastate, as well as interstatejuice (discussed in comments 33 and 74)

• Adoption of the most recentNACMCF definition of ‘‘food hazard’’(comment 39)

• Elimination of the proposedexemption from the regulation for retailestablishments that produce juice ontheir premises and sell 40,000 or lessgallons of juice per year (comment 47)

• Addition of a definition of ‘‘retailestablishment’’ (comment 48)

• Clarification of how a hazardanalysis is conducted (comments 63 to70)

• Clarification of application of the 5-log pathogen reduction performancestandard (comments 115 and 131 to 139)

• Creation of an exemption for shelf-stable juice processors and concentratedjuice processors from the requirementfor a pathogen reduction critical controlpoint, under specific conditions(comment 140)

• Establishment of a processverification sampling and testingprocedure for citrus juices that usesurface treatment as part of the 5-logpathogen reduction process (comment142 to 143)

III. The Final Regulation

A. Applicability

The agency proposed in § 120.1(a)that any juice sold as such or used asan ingredient in beverages be processedin accordance with the requirements ofpart 120 (63 FR 20450 at 20462) (Ref. 2).As proposed, juice is the aqueous liquidexpressed or extracted from one or morefruits or vegetables, purees of the edibleportions of one or more fruits orvegetables, or any concentrates of suchliquid or puree.

(Comment 32) One commentrequested that FDA define juice as theaqueous liquid expressed or otherwiseextracted from food and that thisdefinition should be synonymous withjuice definitions in other regulations,i.e., food standards. One comment notedthat food products (e.g., fruit cocktail)other than beverages contain fruit juice.

FDA advises that the purpose of§ 120.1(a) is to define the scope of whatis covered under part 120 rather than toprovide a general definition for the term‘‘juice.’’ Part 120 only covers productssold as juice or used as an ingredient inbeverages. The agency recognizes thatproducts other than beverages, e.g.,canned fruit cocktail, may contain fruitor vegetable juice. However, thefoodborne illness outbreaks promptingthe juice HACCP proposal wereassociated with juices and juiceproducts that were beverages rather thanjuice ingredients contained in non-beverage products. Therefore, FDA isnot defining ‘‘juice’’ in the general senserequested by the comment.

(Comment 33) Several commentsrequested that FDA clarify whether thejuice HACCP regulation covers onlyinterstate commerce.

FDA intends that this final rule coverboth ‘‘interstate juice’’ (i.e., juice that isshipped in interstate commerce or thatis made using one or more componentsthat were shipped in interstatecommerce) and ‘‘intrastate juice’’ (i.e.,juice that is made entirely fromcomponents grown within a single State

and then sold to the ultimate consumerwithin the same State).

As noted in the proposal, FDA isrelying upon both its authority underthe act, 21 U.S.C. 321 et seq., and thePublic Health Service Act, 42 U.S.C.241, 242l, 264. FDA’s authority toregulate ‘‘interstate juice’’ is discussedin detail below in comment 74. Undersection 361 of the Public Health ServiceAct (42 U.S.C. 264), the Surgeon Generalis authorized to issue and enforceregulations to prevent the introduction,transmission, or spread ofcommunicable diseases from one Stateto another State. (This authority hasbeen delegated to the Commissioner ofFood and Drugs, 5 CFR 5.10(a)(4).)Activities that are wholly intrastate incharacter, such as the production andfinal sale to consumers of a regulatedarticle within one State, are subject toregulation under section 361 of the PHSAct State of Louisiana v. Mathews, 427F. Supp. 174, 176 (E.D. La. 1977). Therecord in this rulemaking amplydemonstrates that juice can function asa vehicle for transmitting foodborneillness caused by pathogens such asSalmonella and E. coli O157:H7.Similarly, the record (Ref. 53)demonstrates that consumers(particularly out-of-State tourists andother travelers) are likely to purchaseand/or consume ‘‘intrastate’’ juice.These consumers subsequently take thejuice back to their home State where thejuice is consumed or carry acommunicable disease back to theirhome State, thereby creating the riskthat foodborne illness may occur in thehome State as a result of suchconsumption.

The agency believes that its intent toregulate both ‘‘interstate’’ and‘‘intrastate’’ juice was evident from§ 120.1(a) of the proposal, which statedthat the requirements of part 120 wouldapply to ‘‘any juice’’ withoutqualification as to its ‘‘interstate’’ or‘‘intrastate’’ character. However, toclarify further the products to whichthis final rule applies, FDA is adding asentence to § 120.1(a) as follows: ‘‘Therequirements of this part shall apply toany juice regardless of whether thejuice, or any of its ingredients, is or hasbeen shipped in interstate commerce (asdefined in section 201(b) of the FederalFood, Drug, and Cosmetic Act, 21 U.S.C.321(b)).’’

(Comment 34) Some commentsrequested that FDA exempt citrus juicesfrom the HACCP regulation becausethese juices contain organic acids thatstop microbial growth, the pH of citrusjuices is too low for pathogen growth,and peel oil contains an antimicrobialagent. One comment included data



indicating that Listeria and E. coliO157:H7 cannot survive in lemon andlime juices under normal storageconditions and requested that these twojuices be exempted from the HACCPrule.

The agency disagrees that citrus juicesshould be exempt from the requirementsof part 120. Although the organic acids,pH, and peel oil in citrus juice mayinhibit (i.e., prevent or slow down) thegrowth of pathogens, such organismscan still be present in citrus juice andmay cause illness if consumed. Fruitsand vegetables differ in their inherentchemical composition; even withinvarieties of particular fruits orvegetables, there can be some variationin composition depending on growingconditions. However, the commentsprovided no data to show how thechemical composition of a citrus juice(pH or antimicrobial compounds in peeloil) will ensure the safety of fresh citrusjuice. In fact, because the amount ofpeel oil in juice will vary from processto process, the agency disagrees that theantimicrobial effects of citrus peel oilcan adequately control pathogens injuice. Similarly, the organic acid incitrus juice (i.e., citric acid) has not beenshown to provide any additionalprotection against pathogencontamination and survival compared tothe acid found in apple juice (Refs. 54,55, and 56).

A 1997 study of E. coli O157:H7behavior in apple juice and orange juice,particularly under refrigeratedconditions, demonstrated that even inthe relatively acidic environment ofthese juices, this organism can survive(Ref. 57). In the study, juice wasinoculated with E. coli O157:H7. Aftera 24-day period at refrigerationtemperatures, there was only a smalldecline in numbers of E. coli O157:H7.The fact that E. coli O157:H7 cansurvive in orange juice and that humanillnesses from other pathogens, such asS. Muenchen and other Salmonellaspecies, have been traced to orange juicedemonstrates that, if contaminated,orange juice has the potential to causehuman illness.

Lemon and lime juices are moreacidic than other types of citrus juice.The strong acidity of these juices doeshave an antimicrobial effect as thecomment’s data demonstrated.However, the resistance of oocysts to thestrong acidity of these juices is notknown. In addition, there can bedifferences in acidity between varietiesof lemons and limes, and thus,differences in their inherentantimicrobial effects. These juices maybe diluted and sweetened to make thempalatable as beverages, thus changing

antimicrobial parameters. In addition,there may be chemical and physicalhazards that are reasonably likely tooccur in these types of juices that pHand acids cannot control. Therefore,FDA concludes that the chemicalcomposition of lemon and lime juicesdoes not justify exempting these juicesfrom this rule. If processors candemonstrate that the inherentantimicrobial qualities of a juice areadequate to accomplish the 5-logreduction in the pertinent pathogenunder refrigerated conditions (orfreezing conditions, if the product isfrozen) prior to the product leaving theprocessing facility, then theantimicrobial parameters, along with thenecessary time to accomplish the 5-logreduction, could constitute CCP’s. FDAnotes, however, that under the finalrule, processors must establish criticallimits and monitor each of the CCP’s aspart of their HACCP systems.

(Comment 35) Some commentsmaintained that there is less inherentrisk from citrus juices because citrusprocessing limits contact time of peeland juice. The comments included datafrom citrus processors that separate thepeel from the juice with only a smallfraction of peel contacting the juice.

The agency disagrees that there is lessrisk from citrus juices such that thesejuices should not be subject to part 120.The significance of peel/juice contact asa source of pathogens in the juicedepends on several factors, includingthe microbial load on the peel and theamount of contact of the peel with thejuice. If the small fraction of peel, asdescribed by the comments, iscontaminated and comes into contactwith the juice, that contact issignificant. As discussed in theproposed rule (63 FR 20450) (Ref. 2) andalso in the response to comment 26,there have been outbreaks of food borneillness associated with orange juice.

(Comment 36) A few commentsrequested that FDA exempt apple ciderfrom the HACCP regulation because theagency found no pathogencontamination in the 1997 cider survey,which, according to the comment,indicates that there is no real risk frompathogens in cider.

FDA’s 1997 survey involvedinspection of fresh unpasteurized applecider operations at 237 processors in 32States (Ref. 45) during which the agencycollected samples at various processingsteps. These samples were analyzed forE. coli O157:H7, Salmonella,Staphylococcus aureus, fecal coliforms,and generic E. coli. Although the surveydid not detect any pathogens in finishedjuice products, one firm’s apples testedpositive for Salmonella, demonstrating

that pathogens can occur on incomingapples. (The analytical method used forSalmonella has since been improved tobetter detect low levels of this pathogenin acidic foods, such as apple juice.)Results also showed that samples ofwash water from several firms testedpositive for generic E. coli and fecalcoliforms; overall, generic E. coli wasfound in 15 percent of the finishedproduct samples. The presence of fecalcoliforms and generic E. coli are widelyrecognized as indicators of fecalcontamination (Ref. 58). Further, thesurvey concluded that it is likely thatany microbial hazards that areintroduced at the beginning ofprocessing will be carried through to thefinished product; no microbialreduction will occur during the process(Ref. 45).

The agency disagrees that theseresults indicate there is no real risk frompathogens in cider. Contrary to thecomments’ contention, the cider surveyresults affirm that risk factors such asfecal coliforms, an indicator of thepossible presence of pathogens, as wellas pathogenic bacteria, such asSalmonella, are present in ciderprocessing operations and could giverise to microbiological safety hazards infinished cider products.

Finally, illness outbreaks associatedwith apple cider continue to occur. Inparticular, in October 1999 inOklahoma, there was an outbreakrelated to E. coli O157:H7 in acommercially produced, unpasteurizedapple cider, that resulted in ninereported illnesses. The agency,therefore, is not granting the requestedexemption.

(Comment 37) Several commentsrequested that FDA clarify whetherconcentrates are covered under the rule.

The agency advises that under thefinal rule, a juice concentrate satisfiesthe definition of ‘‘juice’’ in § 120.1, andthus, producers of concentrates arerequired to comply with part 120.

(Comment 38) One commentrequested that FDA clarify whetherprocessors of beverages that includejuice as an ingredient but do notproduce the juice itself are coveredunder the juice HACCP regulation. Onecomment stated that dairies usingconcentrates that are processed to meetthe 5-log requirement or untreatedjuices that are further pasteurizedshould not be subject to the HACCPregulation.

The agency advises that any juiceprocessing activity, including juiceingredient processing, must complywith the provisions of part 120. Dairiesmaking juice, regardless of whether theyuse concentrates, must comply with part



120. However, dairies producing a non-juice beverage that contains a juiceingredient (e.g., a dairy-based beveragecontaining orange juice) are not requiredto comply with part 120 in terms of theprocess for producing that non-juicebeverage. Processors of juice used as abeverage ingredient must comply withthe provisions of part 120.

B. Definitions

1. Food Hazard

FDA proposed in § 120.3(e) (finalizedas § 120.3(g)) that ‘‘food hazard’’ meansany biological, chemical, or physicalproperty that may cause a food to beunsafe for human consumption.

(Comment 39) One commentrequested that FDA adopt the mostrecent NACMCF definition of a foodhazard to clarify the mechanism bywhich a hazard analysis is conducted.

The agency agrees with this comment.The NACMCF currently defines‘‘hazard’’ as a ‘‘biological, chemical, orphysical agent that is reasonably likelyto cause illness or injury in the absenceof its control’’ (Ref. 17). The definitiondiffers from, but is not inconsistentwith, the definitions for food hazardsused in the seafood HACCP and meatand poultry HACCP regulations.Adopting the most recent NACMCFrecommendations to the extent feasiblewill allow the HACCP regulation toremain current with the science ofHACCP.

In the first step of a hazard analysis,processors must identify all the hazardsthat could potentially occur in the juice.Potential hazards are those microbial,chemical, and physical agents that arereasonably likely to cause illness orinjury regardless of the likelihood oftheir occurrence. FDA intends topublish a juice HACCP hazards andcontrols guidance to assist processors inthis step of the hazard analysis.

Second, processors must determinewhether the potential hazards identifiedare ‘‘reasonably likely to occur’’ in theirparticular process. Under § 120.7(b), ahazard is ‘‘reasonably likely to occur’’ ifa prudent processor would establishcontrols because experience, illnessdata, scientific reports, or otherinformation provide a basis to concludethat there is a reasonable possibilitythat, in the absence of those controls,the food hazard will occur in theparticular type of product beingprocessed.

In the NACMCF’s view, if a hazardhas a severe, acute public health impact(e.g., illness caused by a pathogen,injury caused by ingestion of glass), thathazard presents a significant risk even atan extremely low frequency of

occurrence and must be appropriatelyidentified as a hazard that is‘‘reasonably likely to occur’’ (Ref. 17).FDA concurs in this view. On the otherhand, chronic hazards would need tooccur at a higher frequency to beidentified as a hazard that is‘‘reasonably likely to occur.’’ In the caseof chronic hazards, it must beunderstood that the illness or injuryneed not be caused by any specificoccurrence of the hazard but may occurwith exposure to the hazard over time.Each hazard identified in the hazardanalysis as ‘‘reasonably likely to occur’’requires the identification of at least oneCCP, the critical step or steps in theprocess that must be controlled toprevent, reduce to acceptable levels, oreliminate the hazard.

Because hazards can be either acute orchronic (i.e., having short-term or long-term effects, respectively) and thepurpose of HACCP is to focus on publichealth hazards that are ‘‘reasonablylikely to occur,’’ FDA finds that theNACMCF definition better describeswhat must be considered in a hazardanalysis. Therefore, the agency ismodifying § 120.3(g) to state that a ‘‘foodhazard’’ means any biological, chemical,or physical agent that is reasonablylikely to cause illness or injury in theabsence of its control.

2. ProcessingThe agency proposed in § 120.3(h)(1)

(finalized as § 120.3(j)(1)) to define‘‘processing’’ as activities that aredirectly related to the production ofjuice products. However, for purposes ofproposed part 120, certain activitieswere proposed to be exempted by§ 120.3(h)(2) (finalized as § 120.3(j)(2)).These are: (1) Harvesting, picking, ortransporting raw agricultural ingredientsof juice products, without otherwiseengaging in processing; (2) the operationof a retail establishment; and (3) theoperation of a retail establishment thatis a very small business and that makesjuice on its premises, provided that theestablishment’s total sales of juice andjuice products do not exceed 40,000gallons per year, and that sells the juice(a) directly to consumers or (b) directlyto consumers and other retailestablishments.

a. Harvesting, Picking, andTransporting Raw AgriculturalProducts.

(Comment 40) Several commentsobjected to the definition of processingin proposed § 120.3(h)(2)(i) (finalized as120.3(j)(2)(i)) excluding harvesting,picking, and transporting rawagricultural ingredients of juiceproducts because this will leave a biggap in the farm to table system and

contamination is very likely to occur inthis gap. One comment advocatedmandatory HACCP that either begins atthe farm including harvesting, picking,and transport or includes a ‘‘kill step.’’

The agency has concluded that itwould be unduly burdensome to requirethat harvesting, picking, andtransportation be included as part of aprocessor’s HACCP system or to requirea kill step. Under HACCP, processorsare responsible for evaluating theirproduction system for hazards andestablishing CCP’s. This includes thequality of incoming raw materials. FDAencourages farmers and processors toevaluate and modify their agriculturalpractices in accordance with FDA’s‘‘Guide to Minimize Microbial FoodSafety Hazards for Fresh Fruits andVegetables’’ (Ref. 59). This guidancedocument is based upon certain basicprinciples and practices associated withminimizing microbial food safetyhazards from the field throughdistribution of fresh fruits andvegetables. Farmers should take all stepsto ensure their products are safe for theintended food use, but safe juice can beproduced without these activities at thefarm level coming under the processor’sHACCP system. Processors can controlhazards that may be present onincoming produce by: (1) Rejectingproduce at receipt that does not meetprocessor specifications; (2) removingcontaminated produce during initialprocessing; (3) cleaning and sanitizingproduce; (4) using, as a minimumstandard, the 5-log reduction in thepertinent pathogen as set forth in§ 120.24; and (5) using any othereffective method.

The agency does not believe it isappropriate to mandate a ‘‘kill step’’ inthe absence of HACCP at the farm. It isthe processor’s decision, based on itshazard analysis whether or not the firstCCP in its HACCP system is at the pointof receipt of raw materials, to controlhazards that may have occurred earlier.The hazard analysis must be based onexperience, illness data, scientificreports, or other information thatprovide a basis to conclude that there isa reasonable possibility that, in theabsence of HACCP controls, the foodhazard will occur in the particular typeof product being processed. Theperformance standard establishes theminimum level of microbial pathogenreduction the process must be able toprovide to produce safe juice and thismay be met by a ‘‘kill step’’ or any otherappropriate method. The 5-logreduction in the pertinent pathogen isadequate to ensure that the juice is safewhen done under a HACCP system witha foundation of CGMP’s and SSOP’s.



(Comment 41) One commentsuggested that the definition ofprocessing should at least mentionFDA’s ‘‘Guide to Minimize MicrobialFood Safety Hazards for Fresh Fruitsand Vegetables’’ (GAP’s).

FDA has considered the comment’ssuggestion and believes that reference tothe GAP’s in part 120 would be useful.However, the agency finds that it ismore appropriate to discuss the GAP’sin terms of the application of part 120.Therefore, FDA is modifying § 120.1(a)to state that raw agricultural ingredientsare not subject to the requirements ofthis part and that processors shouldapply existing agency guidance tominimize microbial food safety hazardsfor fresh fruits and vegetables inhandling raw agricultural products.

b. Retail.(Comment 42) Several comments

were opposed to excluding retailestablishments from the definition ofprocessing in proposed § 120.3(h)(2)(ii)(finalized as § 120.3(j)(2)(ii)). Thecomments expressed concern becauseoutbreaks associated with productsprocessed in retail establishments willbe equally devastating to the industry asa whole. One comment stated thatrelying on the Food Code and Stateregulators is inadequate because: (1) Theadoption of Food Code provisions isvoluntary and varies widely on a State-by-State basis and (2) State regulators donot have the resources to inspect retailestablishments on a regular basis.

The agency recognizes that retail is animportant segment of the juice industryand that retailers may also mishandleproducts. FDA is concerned that juicesold at retail be safe. However, retailestablishments pose a unique situationfor the implementation of HACCP.Retail establishments, in general, dealwith a greater variety of products andprocesses at relatively lower volumesthan non-retail producers. For example,cider retailers at farmers’ markets willgenerally sell other products, includingfresh produce, as well as apple cider.Therefore, because retail establishmentshandle lower volumes of a variety ofproducts, HACCP systems at retail aresignificantly different from HACCPsystems in processing plants. Because ofthe wide variety of products andprocesses used by retail establishments,the relatively low volumes of juicesproduced, the normally small area ofproduct distribution, and the largenumber of retail establishments, FDAhas chosen to focus its regulatoryresources on manufacturers thatproduce larger quantities of widelydistributed products.

Even though retail establishments arenot included in this rulemaking,

prudent retailers should take steps toensure the safety of their products. FDAtraditionally provides guidance to theretail industry through the Food Codeand works with the States to implementFood Code provisions. The Statesshould be aware that the Food Code isresponsive to many of the concernsraised in the comment. FDA encouragesjuice retailers to implement Food Codeprovisions. Also, FDA provides trainingand other forms of technical assistanceto States and local Governments whoinspect retail food establishmentsthrough the agency’s retail Federal/Statecooperative program. The agency willcontinue to provide this supportthrough the Federal/State cooperativemechanism. FDA recognizes that not allStates have adopted the Food Code.

Finally, more than 25 States haveadopted the Food Code as law withmost other States in the process ofadopting the Code. However, retailestablishments pose an inspectionburden well beyond the capacity ofFDA. There are not sufficient resourcesto adequately inspect the many retailestablishments in the United States.

Although retail establishments are notcovered in this final rule, they aresubject to § 101.17(g), which requiresthat packaged untreated juice productscarry a statement informing consumersthat the product has not beenpasteurized and, therefore, may containharmful bacteria that can cause seriousillness in children, the elderly, andpersons with weakened immunesystems.

(Comment 43) One commentsuggested that, rather than exempting allretail establishments from the definitionfor processors, only retailers whoproduce in batches of less than 32ounces at a time or who sell product inglass containers that can be washed andreused might be exempted because theless fruit and vegetables that go into abatch, the lower the risk.

The agency agrees with the conceptthat the smaller the batch, the lower themicrobial risk. Larger establishmentsproduce larger quantities of juice thatare often widely distributed. Retailestablishments produce much smallerquantities of juice that are more likely(but not always) consumed locally.Thus, the public health impact of afoodborne illness outbreak associatedwith larger firms is likely to be greater.However, the special considerationsdiscussed in the response to theprevious comment still exist for retailfirms, regardless of batch size.Therefore, FDA concludes that it isappropriate that part 120 excludesoperators of retail establishments fromthe definition of processor.

(Comment 44) One commentrequested that FDA establish nationalstandards for juice processors in theFood Code if the agency excludes retailestablishments from the definition forprocessing. Conversely, severalcomments stated that the provisions ofthe Food Code adequately ensure juicesafety at retail. A few comments statedthat the guidelines developed by theFresh Citrus Juice Task Force incombination with Food Code provisionsare adequate to ensure the safety ofcitrus juice without mandatory HACCPfor retailers.

FDA agrees with the comments thatmaintain that the Food Code describesappropriate controls that can be appliedto reduce juice hazards at retail. Theagency has traditionally relied on theFood Code to provide guidance to retailestablishments. As noted in theresponse to comment 42, FDA will workwith the States through its Federal/Statemechanism. The agency urges retailersto implement State and industryguidance in their establishments toensure the safety of juice.

(Comment 45) One commentsuggested that all juice, like milk,should be pastuerized and FDA shouldnot permit the sale of untreated juicesince raw milk sales are not allowed.

The agency agrees. Under § 120.24(a),processors must include in their HACCPplans control measures that willproduce, at a minimum, a 5-logreduction in the pertinent pathogen.Thus, all juice subject to part 120 willbe treated to control microorganisms.

(Comment 46) One commentrequested information on whichprocessors will not be covered undereither the juice labeling rule or the juiceHACCP rule and which processors, ifany, have a permanent labeling option.

The agency advises that § 101.17(g)requires that any packaged juice ininterstate commerce that has not beenspecifically processed to prevent,reduce, or eliminate the presence ofpathogens must bear the warningstatement. Under this final rule, a juiceretailer as defined in § 120.3(l) is notrequired to establish a HACCP system;however, any juice produced by thatretailer that includes an interstateingredient or is shipped in interstatecommerce must bear the warning labelstatement. Such a retailer may avoid thelabeling requirements by treating itsproduct to achieve a 5-log reduction inthe pertinent microorganism.

c. 40,000 gallon exemption.(Comment 47) Most of the comments

on the 40,000 gallon exemption fromboth large and small processorsrequested that FDA withdraw theexemption in proposed § 120.3(h)(2)(iii)



(the definition of ‘‘processing’’). Thecomments stated that small processorsare just as likely to producecontaminated juice as larger processorsand that company size should notdictate compliance with regulationswhen public safety is at stake. Thecomments also noted that thisexemption does not maximize publichealth protection.

The comments have persuaded theagency to exclude from this final rulethe exemption proposed for very smallretail businesses who sell less than40,000 gallons of juice annually eitherto consumers directly or to otherretailers. FDA agrees that company sizeshould not dictate compliance with foodsafety rules. The agency also agrees withcomments that stated that thisexemption does not protect the publichealth. Although large processing firmscan be responsible for more widespreadoutbreaks than the firms in the proposedexemption because of their broaderproduct distribution, those smallerbusinesses can make juice that maycause an outbreak. Further, otherregulations addressing public healthconcerns (e.g., seafood HACCP in part123 (21 CFR part 123) mandatorypasteurization of milk and milkproducts in 21 CFR 1240.61) do notcontain such exemptions. Therefore, theagency is removing the exemption fromthis final rule. FDA notes that thoseproducers who would have beencovered by the 40,000 gallon exemptionand who are strictly engaged in retailsales would not be required to complywith this final rule consistent with§ 120.3(j)(2)(ii). Juice produced by theseretailers would be required to bear thelabel warning statement as described inthe response to comment 46.

3. Retail Establishment(Comment 48) Several comments

requested that FDA define ‘‘retailestablishment’’ for clarity. Onecomment requested that FDA reviseproposed § 120.3(h) so that retailers whosell to other retailers are covered by thedefinition for processors.

FDA agrees with the comment thatrecommended establishing a definitionof ‘‘retail establishment.’’ The FDA FoodCode has a definition of ‘‘ foodestablishment’’, which, given thepurpose and scope of the Food Code, isessentially a definition of a retailestablishment. In establishing adefinition for ‘‘retail establishment’’ inthis final rule, FDA is relying on thisFood Code definition. The Food Codedefinition of ‘‘ food establishment’’ hasbeen in existence for many years, and isrecognized by the States. The Food Codedefinition includes establishments in

which juice is produced and solddirectly to consumers in stores, fromroadside stands, at farmers’ markets,and in food service operations (such asjuice bars and restaurants).

FDA also agrees with the commentthat requested that juice retailers whosell to other retailers be subject to theHACCP regulation. FDA believes thatthis approach will contribute to publichealth protection. Accordingly, underthis final rule, only a retailestablishment that limits its juicebusiness to direct consumer sales wouldqualify for exemption from therequirements of this HACCP regulation,and would be subject to regulation bythe State in which it operates. Thus, the‘‘retail establishment’’ definition in thisregulation is consistent with the FoodCode, and also describes establishmentsthat are included and excludedspecifically for the purpose of thisregulation. For example, a retailestablishment, central kitchen, orprocessing facility that provides juice tomore than one retail operation (e.g.,juice production operation that providesjuice to outlets of a chain supermarket)would not be considered a retailestablishment that is exempt from thisregulation. However, a retailestablishment that produces juice forsale directly to consumers at thatlocation and at other locations under thesame ownership would be considered aretail establishment exempt from thisregulation. Therefore, the agency isadding a § 120.3(l) to define a ‘‘retailestablishment’’ as an operation thatprovides juice directly to consumers,and does not include an establishmentthat sells or distributes juice to otherbusiness entities as well as directly toconsumers. ‘‘Provides’’ includes storing,preparing, packaging, serving, andvending. (Because the agency isestablishing an additional definition in§ 120.3, it is recodifying the other termsin § 120.3 so that they continue toappear in alphabetical order.)

4. Verification and Validation(Comment 49) Several comments

requested that the terms ‘‘validation’’and ‘‘verification’’ be defined and beused consistent with NACMCFprinciples.

FDA agrees with the comments. Theagency intends that the terms‘‘validation’’ and ‘‘verification’’ be usedconsistent with NACMCF principlesthroughout this final rule. The NACMCFhas established definitions for theseterms that the agency finds useful (Ref.17). According to the NACMCFdefinition, validation is a subset ofverification (Ref. 17). Therefore, in thisfinal rule the agency is amending

§ 120.3(p) and (q) to include theNACMCF definitions of both validationand verification as follows:

Validation means that element ofverification focused on collecting andevaluating scientific and technicalinformation to determine whether theHACCP plan, when properlyimplemented, will effectively controlthe identified hazards;

Verification means those activities,other than monitoring, that establish thevalidity of the HACCP plan and that thesystem is operating according to theplan.

C. Prerequisite Program StandardOperating Procedures

The HACCP proposal discussed twotypes of prerequisite program standardoperating procedures (SOP’s). FDAproposed to require the first type,SSOP’s, in § 120.6. SSOP’s coversanitary conditions and practices before,during, and after processing. The agencyrequested comment (63 FR 20450 at20466) (Ref. 2) on a second prerequisiteprogram to provide control overmaterials as they enter the plant.However, the agency did not propose torequire incoming material SOP’s in part120.

(Comment 50) One comment askedthat if FDA requires prerequisiteprogram SOP’s, the agency should bemore specific about what is to beincluded in the prerequisite programSOP’s. It stated that some SOP’s ensurewholesomeness and quality and shouldnot be a part of HACCP.

The agency advises that it is requiringthat processors implement SSOP’s inpart 120 at this time and not any othertype of SOP. The SSOP’s in § 120.6 doinclude specific standards that must bemaintained. The SSOP’s as described in§ 120.6(a) address insanitary conditionsand are not directed to ensurewholesomeness and quality althoughthey may have a beneficial effect onthese attributes.

1. SSOP’s(Comment 51) Several comments

stated that SSOP’s are covered underCGMP’s and should not also be coveredin HACCP and neither SSOP’s norCGMP’s should be a writtenrequirement for HACCP. One commentstated that SSOP’s should not be writtenfor the same reasons that SSOP’s are notwritten for seafood HACCP. Onecomment stated that prerequisiteprogram SSOP’s should not bemandated and that CGMP’s provide anadequate basis for HACCP. However,other comments maintained that SSOP’sand CGMP’s should be a part of writtenHACCP programs.



It is important to understand thedifference between CGMP’s, SSOP’s,and HACCP. The agency has establishedCGMP’s in part 110. These regulationsprovide general guidance on suchmatters as facility design, materials,personnel practices, and cleaning andsanitation procedures. In § 120.5, FDArequires that part 110 apply indetermining whether the facilities,methods, practices, and controls used toprocess food are safe, and whether thefood has been processed under sanitaryconditions. Processors do not need tomake a record of these activities for FDAreview. However, the agency willcontinue to include in its inspectionsdeterminations of processor compliancewith CGMP’s. All appropriate CGMP’smust be implemented, whether they areincorporated into a processor’s HACCPsystem or not, because they reflectnorms of good processing.

SSOP’s are specific sanitation CGMP’sthat FDA has found are key to thesuccessful implementation of a HACCPsystem. Not all CGMP’s deal withsanitation issues (e.g., contaminationwith aflatoxin or other natural toxins in§ 110.80(a)(3)). As required by§ 120.6(a), SSOP’s emphasize sanitationconditions and practices before, during,and after processing. Because of theimportance of sanitation to a facility,processors must monitor SSOPconditions and practices duringprocessing to at least ensure compliancewith part 110. If sanitation conditionsand practices are not met, processorsmust take corrective actions(§ 120.6((b)). Insanitary conditions candirectly result in food hazards,especially microbiological hazards.Inadequate sanitation has a direct effecton whether the HACCP plan canadequately control food hazards. Forexample, insanitary conditions cancause post process contamination.

Both CGMP’s and SSOP’s have abroad scope. As noted in section II.A,HACCP is a system to identify specificpoints in a particular manufacturersprocess where risks exist and criticalcontrols are needed to control theidentified risks. CGMP’s and SSOP’sboth play an important role in HACCPin that they form the foundation uponwhich the HACCP system is built.

FDA stated in the proposal (63 FR20450 at 20467) (Ref. 2) that the recordsbearing on the monitoring of relevantsanitation conditions and practices andthe agency’s access to such records areessential if SSOP’s are to be part of aneffective regulatory strategy. Althoughthe agency elected not to require writtenSSOP’s under the seafood HACCPregulation, it required that seafoodprocessors establish SSOP’s and

maintain records monitoring anddocumenting corrective actions. Juice issignificantly different than seafood inthat juice is generally consumed as soldwhereas seafood is generally cooked,thus sanitation takes on increasedimportance. Because of the significanceof sanitary conditions, the agencyconcludes that juice processors mustmaintain SSOP records in the samemanner as that required for otherHACCP records.

(Comment 52) One commentrequested that FDA require that thequality and safety of water used in juiceprocessing plants be verified.

The agency agrees that water used injuice processing plants must be safe andof an adequate sanitary quality for itsintended use. This is consistent with theCGMP requirements in § 110.37(a).Section 120.6(a)(1) of this final rulerequires that juice processors haveSSOP’s that address the safety of thewater that comes into contact with foodor food contact surfaces or that is usedin the manufacture of ice. Processorsmust examine the source of the waterused in their facilities and determinethe necessary provisions to ensure thewater’s safety. The processor’sparticular obligations may vary,depending on the source of the water.Water from community water suppliesis tested for many substances and theprocessor can obtain the results of thattesting from the local water authority. Inthe case of well water, processors mustknow that the water they use is safebecause such water could presentpotential hazards. Thus, processorsusing well water need to test the water.Moreover, if substances in the water arehazards that are reasonably likely tooccur, one or more CCP’s must beestablished and included in the HACCPplan.

(Comment 53) One commentrequested that FDA require processorsto monitor for water and cleaningsolution contamination.

FDA believes that, given theregulation as proposed, the requestedrevision is unnecessary. Section120.6(a)(1) already requires processorsto have and implement SSOP’s relatingto water quality and § 120.6(a)(5)requires processors to have andimplement SSOP’s relating to theprotection of food from cleaningcompounds. Processors must monitortheir SSOP’s and take corrective actionsfor sanitation conditions and practiceswhere the specified conditions are notmet (§ 120.6(b)). In addition, processorsmust maintain records that documentmonitoring and any corrective actionstaken (§ 120.6(c)). If either water orcleaning solution contamination is a

hazard that is reasonably likely to occur,one or more control measures must beincluded in the HACCP plan for eachhazard identified.

(Comment 54) One commentrequested that FDA clarify whether§ 120.6(a)(5) permits certain amounts of‘‘no rinse’’ sanitizers to come intocontact with product.

The agency advises that ‘‘no rinse’’sanitizers used according to productdirections do not present acontamination problem and, withappropriate use, their presence wouldnot be considered a violation of§ 120.6(a)(5).

(Comment 55) One commentrequested that FDA set an ‘‘acceptablelevel of infestation’’ for insect controland require that processors use insectlight traps as monitoring devices.Another comment requested that FDArevise § 120.6(a)(8) to read as follows:‘‘Exclusion of pests from the food plantand prevention of contamination frompests within the plant, as well as inpackaging and raw materials deliveredto the plant.’’

FDA disagrees that it should establishan ‘‘acceptable level of infestation’’ forinsects or that it should revise§ 120.6(a)(8) as the comment requested.Exclusion of pests from the food plantis included as a necessary part ofSSOP’s in § 120.6(a)(8). The comment’srequested modification is alreadyimplied in § 120.6(a)(8). Pests arerecognized sources of microbialcontamination, as well as filth, in foods.The agency believes that generally nounusual pest control requirements arenecessary for juice processingoperations beyond the generalrequirements for pest control in all foodprocessing facilities, as laid out in part110. However, if, during its hazardanalysis, a processor identifies pests orcontamination from pests as a foodhazard that is reasonably likely to occurin its particular system, the processorwill need to establish a control measure,critical limits, and a means ofmonitoring.

(Comment 56) One commentrequested that FDA add the following to§ 120.6(b): ‘‘The requirements under thissection shall apply both to theprocessor’s own premises and thepremises of any supplier of rawmaterials and packaging, as far as this isrelevant.’’ The comment concluded thatthis is necessary because packaging andraw materials are particular sources ofcontamination in most food processingplants.

FDA agrees that incoming materialscan be a possible source ofcontamination in juice processing plantsbut points out that the focus of this



regulation is the production of safe juiceby juice processors. Nevertheless,processors are urged to take steps tocontrol hazards before the hazards enterthe processing facility. Under part 120,processors must control food hazards inthe juice products they make. If aprocessor’s hazard analysis indicatesthat a hazard is reasonably likely tooccur in incoming materials, then anappropriate control (such as a supplieragreement concerning that hazard) mustbe a part of the processor’s HACCP plan,and the processor must monitor the CCPand verify supplier performance. Thus,FDA concludes that raw materials andpackaging are already coveredadequately and is not modifying§ 120.6(b) as the comment requested.

(Comment 57) One comment statedthat corrective actions should not berequired for CGMP’s and SSOP’s.

FDA advises that there are nocorrective actions specifically requiredfor CGMP’s in these HACCP regulations.However, part 120 sets forth monitoringand corrective action requirements forSSOP’s. Insanitary conditions create anenvironment in which products maybecome contaminated with pathogens orother substances. If a product becomescontaminated because of insanitaryconditions, it is important thatcorrections be made as quickly aspossible so as not to subjectsubsequently processed product toconditions that could introduce foodhazards. Therefore, processors need tomonitor the performance of SSOP’s toensure that the SSOP’s are functioningas designed, and that any problems thatarise are corrected. The comment didnot provide data to persuade the agencyto conclude otherwise.

(Comment 58) One commentsuggested that FDA only require SSOP’sin a HACCP plan if their control isessential to eliminate or control a publichealth risk, as determined in the hazardanalysis. The comment contended that adistinction must be made betweenfailure to meet sanitation requirementsand failure to meet a food safety/HACCPrequirement. The comment furtherstated that singling out items to beincluded in SSOP’s implies that theother sanitation requirements in part110 are not that important, and this isnot the case. It stated that if FDAestablishes SSOP’s that, at the veryleast, no recordkeeping requirementsshould be associated with SSOP’s.

FDA advises that processors are notrequired to include sanitation controlsin their HACCP plans. Section 120.6(d)allows processors the option ofincluding sanitation controls in theHACCP plan, but they are under noobligation to do so as long as the

sanitation controls are beingimplemented through the SSOP.Insanitary facilities or equipment, poorfood handling, improper personalhygiene, and similar insanitaryconditions create an environment inwhich products may becomecontaminated with pathogens and othersubstances. A processor may determinethat a task normally covered by SSOP’smay be of such importance that it mustbe included in the HACCP plan becauseit controls a hazard that is reasonablylikely to occur. Similarly, an SSOP taskmay simply be more efficiently oreffectively performed under the HACCPplan rather than SSOP controls, andthus, a processor may choose toincorporate the SSOP task into theHACCP system. However, HACCPcontrols generally focus on discretesteps or ‘‘points’’ in a processingsystem, while sanitation and sanitationcontrols generally have broader,plantwide applicability. Thus,sanitation does not always lend itselfwell to HACCP controls. Therefore, theagency is not modifying § 120.6(d) asrequested.

FDA disagrees that singling out itemsto be included in SSOP’s implies thatthe other provisions of part 110 are notimportant. Rather, the items listed in§ 120.6(a) are to assist processors inidentifying and implementing keysanitation activities. Sanitation controls,such as controls preventing use ofcontaminated water in juice making,have a direct impact on the presence orabsence of pathogens during processing,which in turn, directly affects theeffectiveness of the HACCP plan. Nomatter how reliable the process is,insanitary conditions can cause theproduct to become contaminated withpathogens. It is because of the criticalrole that sanitation plays in theproduction of safe juice that FDA isrequiring SSOP’s, identifying specificitems to be included, and requiringrecordkeeping. However, processorsmust comply with all provisions of part110 in addition to having SSOP’s asrequired under § 120.5.

2. Other SOP’s(Comment 59) Several comments

requested that FDA require written,monitored, and verified SOP’s forincoming materials. One commentcontended that reasonable proceduresfor these SOP’s should include no useof dropped apples, no contact withwater that could contain pathogens, nomanure as fertilizer, steam cleaning ofcrates in contact with fruit between lots,and regular inspections of source farmsand orchards. Another commentsuggested that incoming material SOP’s

be required only for producers that donot pasteurize their product.

The agency is not convinced of theneed for mandatory incoming materialSOP’s because these activities may beadequately controlled under the CGMP’sin part 110. However, FDA doesrecognize the value of incomingmaterial SOP’s, and it encouragesprocessors to establish and monitorincoming material conditions andpractices and to take corrective actionswhen needed. Processors must evaluatethe need for controls at all points intheir process, including incomingmaterials. If incoming materials arereasonably likely to present a hazard,then the hazard must be controlled byone or more CCP’s in the HACCP plan,even if a processor has an incomingmaterial SOP.

Many of the controls mentioned in thecomments are addressed in FDA’s‘‘Guide to Minimize Microbial FoodSafety Hazards for Fresh Fruits andVegetables.’’ As noted earlier, FDAencourages farmers and processors toevaluate and modify their agriculturalpractices in accordance with GAPguidance. Processors may include GAP’sin any SOP’s for incoming materials thatthey may establish.

Finally, because all processors,regardless of whether or not theypasteurize, must meet the performancestandard required under § 120.24, aswell as the other requirements of part120, there is no need to differentiatebetween processors for the purposes ofrequiring incoming material SOP’s, andthus, to require more SSOP’s from aprocessor that does not pasteurize.

(Comment 60) One commentrequested that FDA hold a publicmeeting for input on incoming materialSOP’s.

The agency does not believe that sucha public meeting is necessary. Therehave been many opportunities forinterested parties to comment on allissues related to HACCP, includingincoming material SOP’s (see section I.Bof this final rule). FDA requested publicinput in the HACCP proposed rule (63FR 20450 at 20466) (Ref. 2) and in thisfinal rule has considered all significantcomments received. In addition, someissues surrounding incoming materialsfor citrus juices were discussed at thepublic NACMCF meeting in December,1999 (Ref. 12). Finally, FDA intends toissue a juice HACCP hazards andcontrols guidance, which will provideanother opportunity for public input onthe incoming materials issue.

(Comment 61) One commentsuggested that the GAP’s for freshproduce can be used in conjunction



with SOP’s to ensure the safety ofincoming material.

FDA agrees that the use of GAP’s incombination with SOP’s may enhancethe safety of incoming materials. FDA’sGAP’s for fresh produce providevaluable guidance for use in theproduction and post harvest handling ofraw agricultural commodities. As noted,the agency also intends to publish ajuice HACCP hazards and controlsguidance that will provide additionalguidance on ensuring the safety ofincoming materials.

(Comment 62) One comment statedthat HACCP should include arequirement for incoming materialstesting to prevent another outbreak likethe one in 1996.

The agency disagrees that it shouldrequire incoming materials testing inpart 120, although it encouragesprocessors to test incoming materials asappropriate. Testing may be used as acontrol measure for a hazard that isreasonably likely to occur and it mayalso be used to gather information on aproduct or supplier for use in the hazardanalysis. However, testing may not beuseful in all cases. Microbialcontamination of fresh produce isusually at low levels and is notuniformly distributed throughout a lot.Thus, while detecting a pathogen, suchas E. coli O157:H7, would allow aprocessor to avoid using contaminatedproduce, failure to detect pathogens bytesting does not provide assurance thatthe hazard is not present in incomingmaterials. The 5-log reduction in thepertinent pathogen as implemented in aHACCP system provides the assurancethat microbial hazards are under controlthroughout the process. Therefore, theagency is not requiring the testing ofincoming materials.

D. Hazard AnalysisThe agency proposed in § 120.7 that

processors develop a written hazardanalysis to determine whether there arehazards that are reasonably likely tooccur for each type of juice produced bya processor and to identify the controlmeasures that the processor can apply tocontrol those hazards.

(Comment 63) One commentrequested that FDA clarify how a hazardanalysis is conducted. The commentsuggested that FDA emphasize theNACMCF recommendations, includingconsideration of both likelihood ofoccurrence and severity of hazards. Thecomment expressed concern thatwithout considering both the likelihoodof occurrence and severity of hazards,HACCP plans would not be consistentwith international practice and WorldTrade Organization (WTO) obligations,

which state that scientificdeterminations of risk are needed toform a sound basis for food safetystandards.

The agency agrees that the approachoutlined by the NACMCF will bestassist processors in conducting a hazardanalysis. First, processors will benefitfrom using the five preliminary steps setforth by the NACMCF, which are toassemble a HACCP team, describe thefood and its distribution, identify theintended use and consumers of the food,develop a flow diagram that describesthe process, and verify the flow diagram(Ref. 17). Although the agency is notspecifically requiring that processorsuse these preliminary steps, these stepswill aid processors in focusing on theirspecific product and process.

According to the NACMCF,processors must accomplish threeobjectives in the hazard analysis: (1)Identify hazards that are reasonablylikely to occur and their associatedcontrol measures; (2) identify neededmodifications to a process or product sothat product safety is further assured orimproved; and (3) provide a basis fordetermining CCP’s in the HACCP plan(Ref. 17). FDA agrees with theseobjectives.

The first NACMCF objective isaccomplished in three steps. First,processors must list all the potentialhazards that could be present in thejuice. During this step, the processor’sHACCP expert or team reviews theingredients used in the product, theactivities conducted at each step in theprocess and the equipment used, thefinal product and its method of storageand distribution, and the intended useand consumers of the product. A list ofcategories of potential food hazards isfound in § 120.7(c). Based on thisreview, the processor’s HACCP teamdevelops a list of potential biological,chemical, or physical food hazards thatmay be introduced, increased, orcontrolled at each step in theproduction process. A hazard analysismust be conducted for each type of juiceproduct manufactured by the processorbecause different hazards may beassociated with different juice products.(For example, patulin need only beconsidered in apple juice products.)

The processor must then identifythose food hazards that are reasonablylikely to occur. According to NACMCF,this step takes into account both theconsequences of exposure (i.e., severity)and the probability of occurrence (i.e.,frequency) of the health impact of thepotential hazards in question (Ref. 17).FDA agrees with the NACMCFapproach. Accordingly, when applyingthe phrase ‘‘reasonably likely to occur,’’

a processor must consider both severityand frequency of potential hazards. TheNACMCF stated that consideration ofthe likelihood of the hazard’soccurrence is usually based upon acombination of experience,epidemiological data, and informationin the technical literature (Ref. 17). TheNACMCF also stated that considerationshould be given to the effects of shortterm, as well as long-term, exposure tothe potential hazards. Because thisprocess takes into consideration bothfrequency and severity, a potentialhazard may be identified as reasonablylikely to occur even though it occursinfrequently because the public healthconsequences when it does occur are sosevere, e.g., HUS in small children fromE. coli O157:H7 in juice. This approachalso provides greater harmony forinternational trade because it is thesame approach recommended by theCodex Alimentarius Commission, whichis a recognized standard setting body bythe WTO. Hazards that are notreasonably likely to occur do not requirefurther consideration within a HACCPplan but are controlled under CGMP’s.

Identification of control measures is athird step in the first NACMCF objectivein developing a hazard analysis. Forexample, juice processors must identifythe process they will use to achieve the5-log reduction in the pertinentpathogen. This may be pasteurization,surface treatments for citrus, or othereffective methods. Therefore, § 120.7requires that processors identify themeasures that they will apply to controlthe hazards that have been identified asreasonably likely to occur. These controlmeasures must be included in theHACCP plan as well as the hazardanalysis.

Under the second NACMCF objective,processors must review their currentprocess to determine deficiencies incontrolling food hazards and thenidentify the changes that must be madeto ensure that food hazards arecontrolled. For example, some juicebeverages may be thinner or thickerthan others, a characteristic that mayaffect how fast the product flowsthrough the pasteurizer; in this stage ofthe hazard analysis, the processor mustreview its process to determine whetherthe product is flowing through thepasteurizer at a rate sufficient to ensurethat all particles of the juice receive theappropriate treatment in terms of bothtime and temperature to achieve, at aminimum, the 5-log reduction in thepertinent pathogen.

The third NACMCF objective requiresthat processors use the hazard analysisto provide a basis for determining CCP’sin the HACCP plan. For example, some



processors may run different juicebeverages on the same line during thesame day with only a water flushbetween products. If one juice productcontains a potential allergen, such as asoy ingredient, then a possible controlmeasure is that this product be run lastin the day with a thorough cleaning ofthe system before the next day’s startup.

To clarify the necessary steps indeveloping a hazard analysis, as thecomment requested, the agency iscodifying them in § 120.7(a). (Becausethe agency is adding these steps to§ 120.7, it is recodifying the otherparagraphs in § 120.7 for clarity.)

(Comment 64) A few commentsobjected to the requirement of a writtenhazard analysis because the seafoodHACCP regulation does not require awritten hazard analysis. However, somecomments supported such arequirement.

FDA acknowledges that a writtenhazard analysis is not required by theseafood HACCP regulation and believesthat, at the time that the regulation wasestablished, this was appropriate.Although the seafood HACCP regulationdoes not require a written hazardanalysis for agency record review,seafood processors are strongly urged tohave a written hazard analysis to resolvedifferences between the processor andthe agency about whether a HACCP planis needed and about the selection ofhazards, CCP’s, and CL’s.

Since the issuance of the seafoodHACCP regulation, the HACCP conceptand how best to implement HACCP hasevolved in step with industry’sincreasing experience with HACCP; partof that evolution is the idea that thehazard analysis should be written.Processors will have a better HACCPsystem if they document the hazardanalysis process. A thorough hazardanalysis is the key to preparing aneffective HACCP plan. According to theNACMCF, if the hazard analysis is notdone correctly and the hazardswarranting control are not properlyidentified, the plan will not be effectiveregardless of how well it is followed(Ref. 17).

Another aspect of HACCPimplementation that affects the need fora written hazard analysis is theavailability of specially trainedinvestigators. At the time the seafoodHACCP program was established, FDAhad sufficient resources to hire andspecifically train investigators inseafood HACCP, as well as to provideassistance to the industry inimplementing HACCP. With expansionof HACCP into other commodity areas,the agency does not have the resourcesto develop cadres of investigators with

expertise in a single commodity, such asjuice. With a written hazard analysis,investigators can more easily determinewhether processors have adequatelyconsidered all juice hazards and haveadequately identified those hazards thatare reasonably likely to occur.

Even though a written hazard analysisis not required by the seafood HACCPregulation, that regulation, as well asUSDA’s meat and poultry HACCPregulations, require a systematic andcomprehensive hazard analysis. Inaddition, USDA’s meat and poultryHACCP regulations require a writtenhazard analysis. Thus, the onlydifference in the juice final rule and theseafood HACCP regulation is that theanalysis is written, not that it is or is notrequired. FDA believes that theadditional step of recording the hazardanalysis poses no significant burden,economic or otherwise, to juiceprocessors and, on the contrary, hasadvantages for the processor. A writtenhazard analysis provides processorswith a ready record of the decisionsmade in conducting a safety analysis oftheir process, which they may use inevaluating potential changes to thesystem and for discussions withregulatory officials. Further, writtenhazard analyses are useful to processorsin that they help provide the rationalefor the establishment of critical limitsand other plan components. Having thebasis for these decisions available willbe helpful when processors experiencechanges in personnel, especially thoseassociated with the HACCP process, andin responding to unanticipated CLdeviations.

A written hazard analysis need not bea highly detailed document, but it mustreflect consideration of all the potentialhazards that could occur in aprocessor’s system for a product and theprocessor’s decisions about whetherthese hazards are reasonably likely tooccur. The hazard analysis may be assimple as a checklist of potentialhazards and the reason why certaindecisions were made. A written hazardanalysis clearly and rationallydemonstrates that processors haveconsidered all potential hazards,identified those hazards that arereasonably likely to occur and areassociated with their product andprocess, and identified CCP’s and CL’sin their HACCP plan.

(Comment 65) Several commentsstated that HACCP should only coverhazards that are reasonably likely tooccur and that have been documented.

FDA agrees that processors need onlycontrol in their HACCP plan thosehazards that are reasonably likely tooccur and that have been documented.

The hazard analysis is where processorsdifferentiate between unlikely hazardsand hazards that are reasonably likely tooccur in the absence of controls. Thisdetermination is made for each type ofjuice processed in a particular facility.Data such as experience, illness data,scientific reports, or other informationmay be used as documentation as towhether the hazard is reasonably likelyto occur in juice and, if so, how thehazard is best controlled.

(Comment 66) One commentrequested that the agency reviseproposed § 120.7(a) to state generallythat all physical, chemical, andmicrobiological hazards be considered,instead of providing a numbered list ofpotential hazards to be considered inthe hazard analysis.

FDA disagrees that all physical,chemical, and microbiological hazardsmust be considered, but only those thatcan be introduced both within andoutside the particular processingenvironment, including hazards that canoccur before, during, and after harvest.The agency points out that the provisionnow codified as § 120.7(c), simplyprovides guidance in the form of aminimum list of potential physical,chemical, and microbiological hazardsthat processors should consider. The listis not intended to be all-encompassing,and is not so constructed. FDA believesthat this guidance is useful because itprovides detail about the types ofpotential hazards that fall into the moregeneral categories of physical, chemical,and microbiological hazards. For thesereasons, FDA declines to revise§ 120.7(c) as requested.

(Comment 67) Several commentsargued that unapproved pesticideresidues, unapproved food and coloradditives, and food allergens are notappropriate for inclusion in HACCPbecause, categorically, they are not asignificant threat to public health andare already covered by other regulations.One of the comments supported itsclaim of inappropriateness by pointingout that FDA failed to give anyexamples of problems caused byunlawful pesticide residues orunapproved food and color additives.Therefore, it stated, these are notproblems that should be covered byHACCP, but addressed under CGMP’s.

FDA disagrees that certain types ofpotential hazards, such as thosementioned in § 120.7(c), need not beconsidered in a hazard analysis. Forexample, pesticide residues abovetolerance may be potential hazards.However, it is unlikely that pesticideresidues above tolerance will need to beidentified during a hazard analysis ashazards that must be included in the



HACCP plan because they occurinfrequently and the public healthimpact of infrequent exposure is notsevere.

The agency recognizes that there areeffective governmental control programsin place in the United States to assuregenerally that unlawful pesticideresidues are unlikely to occur. Forpesticides, these controls includepesticide registration, applicatorlicensure, and government samplingand enforcement programs. Likewise,unapproved food and color additives aregenerally unlikely to occur in juiceproducts because prudent processorswould not intentionally add them totheir products. Thus, for crops grown inthe United States, a processor mayordinarily conclude that the controls forpesticide use are such that it is notreasonably likely that unlawfulpesticide residues will be present incrops (including residues at levels abovetolerance). A processor is responsiblefor assessing the adequacy of control forpesticide use for crops grown outsidethe United States and determiningwhether such controls are sufficient tomake it unlikely that unlawful pesticideresidues will be present. If foreigngovernmental controls are sufficient,HACCP controls would not likely benecessary in the processor’s HACCPplan. If foreign governmental controlsare not sufficient, the processor mayneed to include appropriate controls inits HACCP plan.

Similarly, unapproved food and coloradditives would be reasonably likely tooccur only if, because of their presencein the production plant and thepotential for formulation errors, therewas a real likelihood that they may beinadvertently added to the product oradded at higher than the allowable rate.A food or color additive may also beused on the product by a processor’ssupplier. This may pose a hazard wherethe food or color additive is a potentialallergen or causes sensitivity reactionsin susceptible individuals. For example,a processor may make several types ofjuice drinks, some containing FD&CYellow No. 5. The likelihood andseverity of a reaction to Yellow No. 5 isa factor that must be considered indetermining whether the unintendedpresence, whether by misformulation orcross contamination, of the ingredient oradditive in a food is reasonably likely tooccur and, therefore, constitutes apotential hazard.

Therefore, the agency concludes thatif unlawful pesticide residues andunapproved food and color additives arehazards that are reasonably likely tooccur, it is appropriate that a processor

identify them in its hazard analysis andinclude them in its HACCP plan.

(Comment 68) Several commentssuggested that pesticide control shouldbe handled as an agreement betweenprocessor and grower, not as a CCP.

The agency advises that if anagreement between a processor and agrower adequately assures that unlawfulpesticide residues will not be a hazardthat is reasonably likely to occur, thencontrols for that particular hazard neednot be included in the HACCP plan.Agreements between processors andgrowers on pesticide issues may beparticularly useful for produce grown inareas where government controls maynot be sufficient to ensure that unlawfulpesticide residues are not a hazard thatis reasonably likely to occur.

(Comment 69) One comment notedthat unapproved food and coloradditives are not an issue for orangejuice because it has a standard ofidentity.

The existence of a standard ofidentity, such as for orange juice ortomato juice, is no guarantee that anunapproved food or color additive hasnot been intentionally or inadvertentlyadded to the juice product. However, asnoted previously, if a processor’s hazardanalysis establishes that unapprovedfood and color additives are not ahazard that is reasonably likely to occur,such additives do not need to becontrolled as part of a HACCP plan.

(Comment 70) One commentrequested that proposed § 120.7(b) bewithdrawn as the list of what aprocessor should evaluate because it isalready covered under part 110 and canbe addressed by prerequisite programs.

The agency stated in the proposal thatit was including in proposed § 120.7(b)(now codified as § 120.7(d)) someelements that would be useful for juiceprocessors to consider in a hazardanalysis (63 FR 20450 at 20468) (Ref. 2).Although CGMP’s and SSOP’s address awide variety of situations and hazards,a particular food hazard may bereasonably likely to occur in the absenceof its control and, therefore, necessitateHACCP controls. To assist processors inidentifying all hazards that arereasonably likely to occur in theirproducts, and their public healthimpact, FDA is, therefore, retaining thelist in § 120.7(d) to guide processors intheir hazard analyses.

(Comment 71) One commentrequested that FDA revise the list ofwhat processors should consider inevaluating the safety of their products toinclude cooling, ice, and water qualityspecifically.

The list in § 120.7(c) simply providesexamples to guide processors and is not

intended to be all inclusive. Ice andwater quality are issues that generallywill be addressed in the SSOPrequirement in § 120.6(a)(1). Therefore,the agency is not modifying § 120.7(c) asrequested. However, because the list in§ 120.7(c) is guidance for processors, itdoes not preclude a processor fromconsidering ice and water quality in itshazard analysis. If ice or water qualityposes a hazard that is reasonably likelyto occur, then the hazard must beaddressed in the HACCP plan.

E. HACCP PlanThe agency proposed that processors

have and implement a written HACCPplan for a given process whenever ahazard analysis of that processestablishes that there are one or morefood hazards that are reasonably likelyto occur during such processing. Thewritten HACCP plan is to include thefollowing seven principles: (1) Conducta hazard analysis, (2) determine thecritical control points, (3) establishcritical limits, (4) establish monitoringprocedures, (5) establish correctiveactions, (6) establish verificationprocedures, and (7) establishrecordkeeping and documentationprocedures. These seven elements arederived from the NACMCF principles ofHACCP.

(Comment 72) One commentrequested that FDA delete the term‘‘during processing’’ in § 120.8(a)because some of the problems in thepast have come from fruit contaminatedon receipt and the term could be readto mean that only hazards that couldoccur during processing should beconsidered in the hazard analysis.

The agency does not agree with thecomment. Section 120.7 requires thatprocessors conduct a hazard analysis todetermine the hazards that arereasonably likely to occur in their juice.If a hazard is reasonably likely to occurin the juice, the source of the hazard isimmaterial. Therefore, FDA is notrevising § 120.8(a) to delete the term‘‘during processing.’’

(Comment 73) One commentrequested that FDA delete proposed§ 120.8(b)(2)(ii) because it appears tocontradict the definition for processingin proposed § 120.3(h)(1) (finalized as§ 120.3(j)(1)). The comment asserted that§ 120.8(b)(2)(ii) states that CCP’s shouldinclude food hazards that occur before,during, and after harvesting, yetprocessing is defined as excludingharvesting, picking, or transporting rawmaterials, which places it beyond thecontrol of a processor.

The agency is not making therequested change because the languagein question, along with the definition of



4 Comments on the seafood HACCP final ruleraised similar questions as to FDA’s authority torequire seafood processors to establish HACCPsystems and to require recordkeeping and recordaccess. In response to the proposed juice HACCPrule, one trade associations filed a copy of itscomments on the seafood HACCP proposal. Theagency’s detailed response to the comments on theseafood proposal, set out at 60 FR 65098–65012, isincorporated by reference into the preamble of thisfinal rule.

processor in § 120.3(k), serves toidentify those who are required tocomply with part 120 and is not a basisfor excluding potential food hazardsfrom consideration. Specifically, thedefinition of processing in § 120.3(j)(1)excludes the activities of harvesting,picking, or transporting raw materialseven if these materials may be intendedfor use in juice processing under§ 120.3(k). Only those engaged in‘‘processing’’ juice are ‘‘processors’’ andare subject to the requirements in part120. However, juice processors areresponsible for addressing the hazardsthat may be present in/on the foodsproduced during their process,including hazards that result fromcharacteristics of the incoming produce.One way to address potential hazardspresented by incoming materials is byexamining those materials whenreceived and rejecting those that maycontain hazards. Another way is toprocess juice in a manner to controlpathogens or other hazards that mayhave been present on incomingmaterials. Therefore, FDA believes thatthe definition of ‘‘processing’’ does notconflict with § 120.8(b)(2)(ii) and is notmaking the requested change.

F. Legal Basis

The agency proposed in § 120.9 thatfailure of a processor to have and toimplement a HACCP system thatcomplies with §§ 120.6, 120.7, and120.8, or otherwise to operate inaccordance with the requirements ofthis part, renders the juice products ofthat processor adulterated under section402(a)(4) of the act (21 U.S.C. 342(a)(4)).

(Comment 74) A number ofcomments asserted that FDA lacks thestatutory authority to require juiceprocessors to establish HACCPprograms. Several comments claimedthat section 402(a)(4) of the act cannotbe read to authorize a broad range ofHACCP controls and to provide that thefailure to observe any of those controlswould render food prepared under suchconditions adulterated within themeaning of section 402(a)(4) of the act.

FDA disagrees with these comments.As shown below, the agency has ampleauthority to require juice processors toestablish HACCP systems.4

FDA is issuing these regulationsunder the authority of the act and thePublic Health Service Act (PHS Act).Specifically, FDA is relying on sections402(a)(4) of the act and 701(a) of the act(21 U.S.C. 371(a)) and section 361 of thePHS Act (42 U.S.C. 264).

Under section 402(a)(4) of the act, afood is adulterated if it has beenprepared, packed, or held underinsanitary conditions whereby it mayhave been contaminated with filth, orwhereby it may have been renderedinjurious to health. It is important torecognize that section 402(a)(4) of theact addresses conditions that mayrender a food injurious to health, ratherthan conditions that have actuallycaused the food to be injurious. SeeUnited States v. 1,200 Cans, PasteurizedWhole Eggs, Etc., 339 F. Supp. 131, 141(N.D. Ga. 1972). See also United Statesv. H.B. Gregory, Co., 502 F.2d 700, 705(7th Cir. 1974), cert. den. 422 U.S. 1007(1975). As noted in the notice ofproposed rulemaking, 63 FR 20450 and20457 (Ref. 2), the question is whetherthe conditions of a juice processingoperation are such that it is reasonablypossible that the juice produced by thatoperation may be rendered injurious tohealth. Based upon the informationavailable to the agency and filed in therecord of this proceeding, FDA hasconcluded that, if a juice processor doesnot incorporate certain basic controlsinto its procedures for preparing,packing, and holding juice, it isreasonably possible that the juice maybe rendered injurious to health and,therefore, adulterated under the act.FDA is authorized by 21 U.S.C. 371 toadopt regulations for the efficientenforcement of the act.

FDA believes that the commentsdisputing the agency’s authority to issuethese regulations advocate an undulynarrow interpretation of the actgenerally and of section 342(a)(4)specifically. It is well-settled that the actis to be interpreted broadly so as toachieve its goal of public healthprotection. United States v. Bacto-Unidisk, 393 U.S. 784, 798 (1969).Section 402(a)(4) of the act deemsadulterated food that is prepared,packed, or held under ‘‘insanitary’’conditions. The term ‘‘insanitary’’ is notdefined in the act. ‘‘Sanitary’’ describesthat which ‘‘pertains to health, withespecial [sic] reference to cleanlinessand freedom from infective anddeleterious influences,’’ Black’s LawDictionary, 6th Ed.(1990); use of theprefix ‘‘in’’ denotes the absence oropposite of sanitary. Thus, ‘‘unsanitaryconditions’’ are those that contribute tounhealthiness generally, including

unclean conditions or those thatpromote infection or disease.

The case law interpreting section402(a)(4) of the act is consistent withthis broad reading of ‘‘insanitaryconditions.’’ In particular, in UnitedStates v. Nova Scotia Food ProductsCorp., 568 F.2d 240 (2d Cir. 1977), theSecond Circuit rejected a restrictivereading of 402(a)(4) of the act,concluding that this section providedthe FDA with authority to establish byregulation processing parameters tocontrol or eliminate harmful substancespresent in food intended for furtherprocessing. See United States v. NovaScotia Foods, 417 F.S. 1364, 1368–1369(E.D.N.Y. 1976), aff’d supra, 568 F.2d240. At issue in Nova Scotia were FDA’sregulations governing the time,temperature, and salinity for processingsmoked fish, 568 F.2d at 243, 247 to248, and provisions designed tominimize the outgrowth and toxinformation of Clostridium botulinumType E, 568 F.2d at 243. The regulationsin question defined sanitary conditionsfor processing such fish; fish processedunder conditions not complying withthe regulation were deemed adulteratedwithin the meaning of section 402(a)(4)of the act, 21 CFR 128a.2 (1971); 35 FR17401 (November 13, 1970) (Ref. 60).Although the Court posited that‘‘insanitary conditions’’ could benarrowly interpreted to refer toinsanitary conditions in the plant, suchas the presence of insects and rodents,the Court rejected this narrowinterpretation, 568 F.2d at 245 to 246,and held that under section 402(a)(4) ofthe act, ‘‘insanitary conditions’’ mayinclude ‘‘inadequate sanitary conditionsof prevention’’ (568 F.2d at 247). Inrejecting the narrower reading of402(a)(4) of the act, the Court recognizeda ‘‘larger general purpose on the part ofCongress in protecting the publichealth’’ (568 F.2d at 248).

This final rule requires that juiceprocessors implement and maintainHACCP systems. As discussed in detailabove, HACCP systems are designed toprevent, control, or eliminate hazardsthat are reasonably likely to occurduring food production, includinghazards that are present in in-comingmaterials, such as pathogens and othercontaminants. Under the final rule,§ 120.9, the failure of a juice processorto establish and maintain an adequateHACCP system renders juice producedunder that system adulterated withinthe meaning of section 402(a)(4) of theact. Thus, the provisions of this finalrule are essentially comparable to thoseaddressed in Nova Scotia.

In addition, FDA relies on itsauthority under the Public Health



Service Act in issuing this regulation tothe extent that the regulation seeks tocontrol illnesses caused by pathogenicmicroorganisms. Under section 361 ofthe PHS Act (42 U.S.C. 264), theSurgeon General is authorized to issueand enforce regulations to prevent theintroduction, transmission, or spread ofcommunicable diseases from one Stateto another State; this authority has beendelegated to the Commissioner of Foodand Drugs, 5 CFR 5.10(a)(4). See Stateof Louisiana v. Mathews, 427 F. Supp.174, 176 (E.D. La. 1977). The record inthis rulemaking amply demonstratesthat juice can function as a vehicle fortransmitting food-borne illness causedby pathogens such as Salmonella and E.coli O157:H7. Juice produced in oneState and shipped and sold in anotherState may be contaminated withpathogens and thus may result in thetransmission of food-borne illness fromState to State. The record similarlyestablishes that juice may be producedand sold to a visiting consumer in oneState, with the consumer subsequentlytaking the juice to a second State. Giventhat juice can function as a vehicle fortransmitting human pathogens, thissituation creates the possibility thatfood-borne illness will be transmittedfrom one State to another. In light of therecord of this proceeding, FDA hasconcluded that a system of HACCPcontrols is necessary to prevent thespread of communicable disease viaconsumption of contaminated juice, andthat the PHS Act provides the agencywith the authority to establish suchHACCP requirements for juice.

(Comment 75) Several commentschallenged the agency’s authority torequire that certain records bemaintained and that FDA be grantedaccess to those records. The thrust ofthese comments is that the act does notexplicitly authorize the agency torequire food processors to maintainrecords or to require access to recordsmaintained by food processors. Thecomments observed that section 704 ofthe act (21 U.S.C. 374), the act’s generalrecords access provision, containsspecific authorization for agency accessto records relating to drugs andrestricted medical devices but that, byits terms, the authority of section 704does not extend to records relating tofoods. Thus, the comments concludethat the records access provisions of thejuice HACCP proposal are unlawful.

FDA disagrees with this commentbecause the agency has adequateauthority under the act and the PHS Actboth to require the maintenance ofrecords and to compel official access tosuch records for the efficientenforcement of the act. Importantly,

FDA is not relying on its authority insection 704 of the act to require thekeeping of HACCP records and torequire official access to such records.As discussed in the response to theprevious comment, in terms of the act,this final rule implements section402(a)(4) and utilizes FDA’s authority insection 701(a) of the act to issueregulations for the efficient enforcementof the act. FDA is similarly relying onsections 402(a)(4) and 701 to establishthe recordkeeping and access to recordsrequirements of this rule. That this issufficient authority is established in thecaselaw.

In particular, in NationalConfectioners Assoc. v. Califano, 569F.2d 690 (D.C. Cir. 1978), the D.C.Circuit held that FDA had authority toestablish recordkeeping requirementsfor food processors. In Confectioners,the recordkeeping provisions of theregulations were challenged on thegrounds that they would permitprosecution where processingconditions were completely sanitary,but required records were deficient.Such an outcome, it was argued, wouldbe beyond the scope of section 402(a)(4)of the act, one of the particular sectionsrelied upon as authority for theregulation as a whole. The court rejectedthis argument, holding that theprincipal consideration was whether thestatutory scheme as a whole justified theregulations. Although the records inquestion in Confectioners were codingand distribution records that FDAdesired in order to facilitate recalls, thecourt’s ruling as to the validity of theregulations was not limited to recalls orshipping records. Indeed, Confectionersis appropriately read to authorize FDAto establish regulations that have alimited scope, are not unreasonablyonerous, and clearly assist in theefficient enforcement of the act (569F.2d 693 n. 9). In addition, theConfectioners court recognized thatFDA has a role both in preventing andin remedying commerce in adulteratedfoods, and that the act imposes on theFDA an equal duty to perform each role(569 F.2d at 694).

It is widely accepted thatrecordkeeping and inspectional accessto records are essential components of aHACCP-type system. Through recordsmaintenance and review, a processorcan, over time, develop acomprehensive picture of its processand identify shortcomings or potentialshortcomings. Similarly, recordsmaintenance and access provide theappropriate regulatory authorities withthe opportunity to oversee, in acomprehensive way, the operation ofthe processor’s HACCP plan, thereby

ensuring that contaminated juiceproducts will not enter the marketplace.

Like the records at issue inConfectioners, the records at issue withrespect to this final rule are designed toprevent the introduction into commerceof adulterated foods (569 F.2d at 694).In this case, the recordkeeping andaccess required under this final rulemeet the Confectioners test. First, therequirements are limited. The HACCPrecordkeeping and record accessrequirements in the final rule are tiedspecifically to the CCP’s, i.e., thosepoints in the process at which controlis essential if there is to be assurancethat the resultant product will not beinjurious to health is to be achieved.Second, this limited amount ofrecordkeeping assists FDA in theefficient enforcement of the act. Byfocusing on the CCP’s, the requirementsensure that the processor and the agencyfocus on those aspects of processing thatpresent the greatest threat to food safety;by documenting whether the HACCPplan and its preventive controls arebeing followed, these records enableregulators to verify proper operation ofthe HACCP system or identifymalfunctioning of the system, againensuring that adulterated foods are notproduced and distributed to consumers.As such, the record-keepingrequirements assist in the effective andefficient enforcement of the act. Finally,the HACCP recordkeeping burden is notunduly onerous because the requiredrecords are limited to the developmentof appropriate controls anddocumenting those aspects ofprocessing that are critical to foodsafety. The documentation required inthe final rule is narrowly tailored toensure that only essential informationneeds to be recorded and maintained.Because the preventive controlsrequired by HACCP are essential to theproduction of safe food as a matter ofdesign, the statutory scheme is benefitedby agency access to records thatdemonstrate that these controls arebeing systematically applied.

Similarly, FDA’s authority under thePHS Act (42 U.S.C. 264), provides aseparate and sufficient basis for therecordkeeping and records accessprovisions of this rule, at least to theextent that these requirements relate tothe transmission of communicabledisease. The record of this proceedingclearly shows that juice can function asa transmitter of human disease causedby foodborne pathogens, such asSalmonella and E. coli O157:H7.Likewise, the record demonstrates that asystem of preventative controls, such asthose based upon HACCP, will controlor eliminate this risk from juice



consumption. As discussed in moredetail below, records for the HACCPoperation, and official access to theserecords, are central to the effectivenessof HACCP. Thus, the PHS Act clearlyauthorizes the records maintenance andaccess requirements of this final rule.

(Comment 76) A few commentsstated that the factual and legaljustifications for mandatory HACCPrelate to the presence of pathogens inthe final product, which is not true ofthe pasteurized juice industry.Comments maintained that section402(a)(4) of the act does not authorize abroad range of controls and that seafoodHACCP was predicated on theconclusion that there were sufficienthazards in all fishery products. Onecomment stated that the factualpredicate relied upon in the seafoodrule does not exist for juice. Thecomment maintained that a review ofthe data in the proposed rule indicatesthat microbiological hazards gave rise tothe entire HACCP proceeding and thesehazards do not exist in pasteurized andshelf stable juices.

The agency addressed the legalauthority for this rule in the response tocomment 74. FDA disagrees that thefactual predicate for juice HACCP is notadequate. The record demonstrates thatthere are significant potential hazards inthe production of juice, includingpasteurized and shelf stable juices.These potential hazards in juice can bedivided along the lines of the NACMCFfood hazard definition: Microbiological,chemical, and physical. Microbiologicalhazards can be controlled with sometype of heat treatment or other processthat prevents, reduces, or eliminates thepathogens. Chemical hazards are notnormally affected by heat and othertreatments that are used to reduce themicrobial contamination of foods andthus, must be controlled by other means(e.g., rejection of incoming materialswith high lead levels). Likewise,physical hazards must be controlled insome manner other than by thermal orequivalent treatments. All three types ofhazards require that the specific hazardbe identified (e.g., bacterial species;mycotoxin identity; foreign matterpresent, such as glass), a means forpreventing or controlling the hazardidentified, and the means of controlconsistently and effectively used. Thepublic health effects of microbialhazards are most often acute, althoughlong-term, chronic effects have beenidentified (e.g., arthritis). Chemicalhazards are most often associated withchronic adverse health affects, althoughthey may also have immediate, acuteaffects (e.g., excess tin leaching fromcontainer lining can cause vomiting).

Physical hazards cause acute healthaffects, such as cuts in the mouth fromglass or metal fragments in the food.These hazards are discussed in moredetail below.

Microbial hazards—There is a longhistory of foodborne illness outbreaksassociated with microbialcontamination of a variety of juices. Thepublic health consequences may beminimal (some gastrointestinal distress),severe (hospitalization, HUS), or fatal.Among the pathogens that have beenassociated with juices are E. coliO157:H7, Salmonella, Cryptosporidium,and certain viruses. Identified sources ofpathogens include water, fruit,processing under insanitary conditions,and infected workers and food handlers.

Juices, particularly fruit juices, havetraditionally not been consideredvehicles for human pathogens. Fruitjuices, in particular, are acidic, and suchacidity generally would inhibit thegrowth of most pathogens. Over the pastfew decades, however, it has becomewell documented that some pathogenshave adapted to this acidicenvironment, making juices susceptibleto microbial contamination andsubsequent survival of the pathogens inthe juice products.

Regarding the comment thatpasteurized juices should not be subjectto HACCP, is without foundationbecause ‘‘pasteurized’’ products maypotentially contain chemical or physicalhazards. HACCP systems control alltypes of food hazards, not just themicrobial hazards that adequate heattreatments will control. In recognition ofthe lethality of the heat treatment thatshelf stable and concentrated juiceproducts receive, FDA has modified thepathogen control requirements in§ 120.24 for these product groups. Thismodification to the proposed rule isdiscussed in detail in the response tocomment 140.

Chemical hazards—There is also ahistory of foodborne illness outbreakscaused by a variety of chemical hazardsin foods. These hazards include thepresence of tin, lead, and poisonousplant materials. FDA recall data showthat additional types of chemicalsubstances with the potential to causeillness or injury have triggered recalls ofproducts from the market (e.g., foodingredients that cause allergic-typereactions such as FD&C Yellow No. 5),cleaning solutions, copper from copperpipe fittings on processing equipment.Symptoms of reported juice outbreaksusually are limited to acutegastrointestinal effects. Chronic effectsof chemical contaminants are difficult toassess because long-term monitoring ofthe health of individuals that experience

illness or injury caused by chemicalhazards is required and there are nodata indicating that this type ofmonitoring occurs. Some chemicalhazards, such as patulin, have knownchronic effects of sufficient publichealth concern that FDA is in theprocess of issuing guidance documentsconcerning maximum levels that shouldbe present in foods (Refs. 19 and 24).

Sources of chemical contaminants injuices include packaging materials,plant (botanical) material, processingand cleaning equipment, formulationerrors, contaminated ingredients, andcontaminated fruit (e.g., patulin inapples). Unlike microbial contaminants,chemical contaminants cannot bedestroyed or easily removed fromcontaminated foods, and thus,appropriate controls must be establishedto prevent the contamination in the firstinstance.

Physical hazards—FDA recall dataindicate that glass and fragments ofother packaging materials frequentlycause companies to recall juiceproducts. However, the agency has nodata on illnesses or injuries caused bythose packaging materials.

(Comment 77) One comment statedthat United States vs. Nova Scotia FoodsProducts Corporation cannot be read toauthorize HACCP controls. Thecomment maintained that this casecannot be said to support FDA’sproposal to impose a complex anddetailed regulatory scheme onpasteurized products. Additionally, thecomment stated that since FDA cannotdemonstrate a need or legal justificationfor HACCP for pasteurized products, itsauthority to require recordkeeping andrecord inspection under such a HACCPprogram has no statutory basis.

In the response to comment 74, theagency has explained at some length thebasis for its reliance on United States v.Nova Scotia Foods, 417 F.S. 1364,1368–69 (E.D.N.Y. 1976), aff’d supra,568 F.2d 240. Similarly, in the responseto comment 75, FDA has explained atlength the legal basis for therecordkeeping and records accessprovisions of this final rule. In sum,both the rule itself and therecordkeeping provisions are clearlyauthorized by the act and the PHS Act.

G. Corrective ActionsFDA proposed to require in § 120.10

that processors take appropriatecorrective actions whenever a deviationfrom a critical limit occurs. Allcorrective actions must be fullydocumented in records and are subjectto verification under § 120.11(a)(iv)(B).

(Comment 78) One commentrequested that FDA revise § 120.10(a)(1)



and (b)(3) to remove the wording‘‘otherwise adulterated’’ because itbroadens the scope of the rule beyondfood safety and the focus of HACCPshould be on food safety. The commentfurther stated that adulteration iscovered in part 110 and should not alsobe covered in part 120.

The agency disagrees that therequested revisions are necessary.HACCP plans only address food hazardsthat are reasonably likely to occur.Under § 120.3(g) a ‘‘food hazard’’ isdefined as ‘‘any biological, chemical, orphysical agent that is reasonably likelyto cause illness or injury in the absenceof its control.’’ Thus, a HACCP plan isalready focused on food safety. FDAalso disagrees that adulteration isaddressed exclusively by part 110. Infact, the legal basis for this final rule is,in part an adulteration provision,402(a)(4) of the act and juice notprocessed under conditions notcomplying with this final rule isadulterated (see § 120.9).

(Comment 79) A few commentssuggested that in § 120.10(b)(5) thewords ‘‘timely validation’’ probablyshould be ‘‘timely verification’’ or‘‘timely review’’ and that in§ 120.13(a)(3) the term ‘‘verifying’’should be used in place of ‘‘validating’’to be consistent with NACMCF’sHACCP guidelines.

The agency agrees with thecomments. When there is a processdeviation, processors must undertake areview to see if there have beensufficient changes such that arevalidation of the HACCP plan iswarranted. The fact that processors havediscovered a deviation indicates that theHACCP plan is working. Therefore, FDAis modifying § 120.10(b)(5) to use theterm ‘‘timely verification’’ and§ 120.13(a)(3) to use the term‘‘verifying.’’ As noted previously, theagency is defining the terms‘‘validation’’ and ‘‘verification,’’ in§ 120.3(p) and (q), respectively.

H. Verification and Validation(Comment 80) One comment

requested that FDA not require a reviewof consumer complaints in the HACCPprogram. The comment maintained thatreview of consumer complaints isuntimely because the product hasalready been processed and reached theconsumer. Additionally, the commentstated that consumer complaints, or lackthereof, cannot attest to the effectivenessof a process. Another commentsuggested that it should be up to themanagement to determine whichconsumer complaints need followup inrelation to HACCP compliance. Onecomment stated that only consumer

complaints that indicate a deviationshould be held for HACCP review.

The agency disagrees that processorsshould not review consumer complaintsas part of their HACCP programs. Theagency recognizes that review ofconsumer complaints is of limited useas a preventive tool because theconsumer making the complaint alreadyhas the product. However, such reviewmay alert the processor to a problemthat, if resolved, would preventrecurrence of the problem with otherconsumers. The agency also recognizesthat the receipt or absence of complaintsdoes not alone attest to the adequacy ofa HACCP system. However, it is FDA’sexperience that consumer injury orillness complaints can identifyproblems traceable to inadequatecontrols at the food processing facility(Ref. 61). Where information that haspotential relevance to food safety isavailable to a processor as a result of itsown consumer complaint system, it isentirely appropriate for the processor toconsider that information in assessingthe adequacy of its HACCP program.FDA concludes, therefore, thatprocessors should evaluate, as part oftheir HACCP verification procedures,the consumer complaints that theyreceive to determine whether thecomplaints relate to the adequateperformance of control measures orreveal unidentified hazards.

FDA agrees that it is up tomanagement to determine whichconsumer complaints need followup inrelation to HACCP compliance as part ofits verification procedures. This finalrule does not require that processorshold consumer complaints for HACCPrecord review, except as the processordeems necessary as documentation ofverification procedures.

(Comment 81) One commentrequested that FDA revise§ 120.11(a)(1)(iii) by adding at the end ofthe sentence ‘‘where these are otherthan standard operating procedures orCCP’s’’ to clarify that testing requiredunder standard operating procedures orCCP’s is not optional.

The agency disagrees that therequested revision of § 120.11(a)(1)(iii)is appropriate. The requested revisionwould make the testing mandatory aspart of verification activities for SOP’sand CCP’s. This was not the intent ofthe provision. In the preamble to theproposal, the agency acknowledged theshortcomings of end-product testing asa process control, especiallymicrobiological testing, but encouragedinclusion of testing in HACCP systemswhere it is appropriate. SOP’s and CCPmonitoring requirements do notnecessarily need to be end-product or

in-process tested, except where FDA isrequiring end-product testing.Monitoring could consist of ensuringthat the product was processed withintime/temperature parameters or time/sanitizer concentration parameters.Therefore, FDA is not making therequested modification.

(Comment 82) One commentsuggested that verification shouldinclude actual times and temperaturestaken and recorded and that thereshould be penalties for noncompliance.

The agency agrees with the comment.Verification activities include timelyreview of monitoring records inaccordance with § 120.11(a)(1)(iv).Monitoring records must include actualmeasurements (e.g., times andtemperatures) in accordance with§ 120.8(b)(7), except as exempted by§ 120.24. Consequently, verificationmust include checking the actualmeasurements that are recorded in themonitoring records. As proposed, therule has an enforcement mechanism.Specifically, under § 120.9, failure of ajuice processor to have and toimplement a HACCP system inaccordance with part 120 will renderthe juice products of that processoradulterated under section 402(a)(4) ofthe act. Penalties for noncompliance areFDA refusing entry to importedproducts and instituting legal actionssuch as seizure, multiple seizures, orinjunction, against unlawful products ortheir producers.

(Comment 83) One commentmaintained that weekly review ofproduction records is inadequate andsuggested that records be reviewedbefore each batch of product leaves theplant.

FDA disagrees with the comment. Theagency stated in the proposed rule thatweekly review of HACCP monitoringand corrective action records wouldprovide the industry with the necessaryflexibility to move a highly perishablecommodity like fresh juice throughprocessing and distribution withoutinterruption, while still facilitatingtimely feedback of information. FDAnotes that the comment provided noinformation to demonstrate that weeklyreview of records is inadequate. In fact,weekly record review will quicklyindicate whether the HACCP system isout of control on a regular basis, whichis a sign that the system is not adequateto assure safety and that revalidation ofthe system is required. Thus, the agencyconcludes that weekly review ofmonitoring and corrective actionrecords is adequate for verificationpurposes. FDA notes that therequirement for weekly review does notpreclude a processor from reviewing



production records on a more frequentbasis if the processor wishes to do so.

(Comment 84) One commentsuggested that FDA revise§ 120.11(a)(1)(iv)(A) to provide forvalues that are outside critical limitsand for which corrective actions aretaken (covered in § 120.11(a)(1)(iv)(B)).

The agency disagrees that therequested revision of§ 120.11(a)(1)(iv)(A) is necessarybecause under § 120.11(a)(1)(iv)(B)processors must review records toensure that the records are complete andto verify that appropriate correctiveactions were taken. Therefore, FDA isnot making the requested modification.

(Comment 85) Several commentspointed out that the proposed annualvalidation requirement in § 120.11(b) isnot consistent with NACMCF HACCPguidelines. The comments requestedthat, instead, FDA require validationwhenever there are significant processchanges or equipment/system failures.

The agency is not persuaded that itshould modify the requirement forannual validation. Section 120.11(b) isconsistent with the NACMCF HACCPguidelines in that processors mustvalidate their process as needed (Ref.17). The NACMCF provided asexamples whenever there is anunexplained system failure; a significantproduct, process or packaging changeoccurs; or new hazards are recognized.FDA has simply defined ‘‘as needed’’ asat least annually or whenever anychanges in the process occur that couldaffect the hazard analysis or alter theHACCP plan in any way. Therefore,FDA is not modifying § 120.11(b) as thecomments requested.

(Comment 86) One commentrequested that FDA not require aprocessor to validate the HACCP planany time changes occur in theprerequisite programs. The commentrequested that FDA revise § 120.11(b) todelete this requirement.

The agency agrees with the comment.It is rare that a change in SSOP’s willmake the HACCP plan ineffective.Validation is not a paper exercise andmay be time consuming and expensive.Therefore, FDA is modifying § 120.11(b)to delete the proposed requirement.FDA notes that the final rule requiresrevalidation when there is any changein the process, including a change in theSSOP’s, that decreases the effectivenessof the HACCP plan.

(Comment 87) One commentexpressed concern that the proposedvalidation requirements would have theeffect of locking producers into onesupplier and that this would stopproduct development and innovation.

The agency does not agree with thecomment. All food processors must takesafety considerations into account whencontemplating changes in theirprocesses, regardless of whether theyare operating under a HACCP system.The agency recognizes that validationcould be costly if frequent changes aremade in the process that could affect thehazard analysis or alter the HACCP planand, thus, processors may be reluctantto make changes, even if the changeshave the potential to improve theprocess or the safety of the finalproduct. A change in the supplier of rawingredients may be a change requiringrevalidation. However, a prudentprocessor will check new suppliersbefore making any changes to determinethat the supplier will not be a source ofany safety concerns. Because HACCPsystems need to be revalidated onlywhen changes in the process occur thatcould affect the hazard analysis or alterthe HACCP plan in any way, not everychange will require revalidation.Similarly, because a hazard analysisneeds to be revalidated only when thereare process changes that couldreasonably be expected to affect whethera food hazard exists, not every processchange will require revalidation of thehazard analysis. Therefore, FDAconcludes that the requirements of§ 120.11(b) and (c) are important for thepublic safety and will have minimumimpact on conscientious processors.

I. RecordsThe agency proposed that processors

maintain records documenting theirHACCP system. FDA also proposedgeneral record requirements, and otherprovisions or requirements dealing withdocumentation, record retention, officialreview, public disclosure, and recordsmaintained on computers.

(Comment 88) One comment wasconcerned that the agency was trying toget access to processors’ CGMP recordsunder § 120.12(a)(1) and that this couldbe a disincentive for companies to keepthorough records.

The agency disagrees with thecomment. Section 120.12(a)(1) requiresthat processors maintain recordsdocumenting the implementation of theSSOP’s in § 120.6. SSOP’S are selectCGMP sanitation requirements that theagency believes are so important to theeffective implementation of HACCP thatthey require separate, specificprovisions. The agency believes that thesanitation controls in § 120.6 are ofsignificant importance to the properimplementation of HACCP becausesanitation controls, such as controlspreventing contamination from pests,have a direct impact on the presence or

absence of pathogens during processing,which in turn, directly affects theeffectiveness of the HACCP plan. Accessto specific SSOP records is important toinvestigators making reasonablejudgements about whether the HACCPplan is working properly. Accordingly,the final rule requires that SSOP recordsmust be maintained and made availableduring inspections. However, theagency has no intention of requiring,and processors need not make availableto FDA, any other CGMP-relatedrecords.

(Comment 89) One commentrecommended that the agency deletefrom the regulation any reference torecords for end-product or in-processtesting. The comment stated thatindividual processors would keeptesting records for FDA review only if itis part of the verification of theirHACCP plan.

The agency disagrees that anymodification of the regulation isnecessary and is not making therequested change. The regulation onlyrequires that end-product or in-processtesting records associated withverification of the HACCP plan beavailable for FDA review and thus, isconsistent with the comment. Asdiscussed in section III.L.6, the agencyis establishing periodic end-producttesting requirements for purposes ofprocess verification of citrus juices thatuse fruit surface treatment to achievethe 5-log reduction in the pertinentpathogen; processors are required toprovide FDA with access to theserecords.

(Comment 90) One comment statedthat a processor with only one locationshould not have to provide its locationon all records, as required in§ 120.12(b)(1).

The agency agrees with the commentand is modifying § 120.12(b)(1) to readas follows: ‘‘The name of the processoror importer and the location of theprocessor or importer, if the processoror importer has more than onelocation.’’

(Comment 91) Two comments statedthat date and time may not be necessaryon all records. One comment contendedthat the date and time are onlyimportant on monitoring and correctiveaction records and, therefore, shouldonly be required on these records.

The agency believes that the date ofthe activity is important on all HACCPrecords. The date allows the processorand the FDA investigator to assesswhether the record is current, toidentify when any deviation occurred,and to track corrective actions.However, the time of an activity is notnecessary on records other than



monitoring and corrective actionrecords (i.e., it is not necessary on thehazard analysis or HACCP plan).Therefore, the agency is modifying§ 120.12(b)(2) to state that the time ofthe activity need not be included onrecords required under § 120.12(a)(2),(a)(3), and (a)(5).

(Comment 92) One commentsuggested that there is no need for thehazard analysis to be signed unlessthere is no HACCP plan because thehazard analysis did not indicate theneed for a HACCP plan.

FDA disagrees with the comment. Thesignature of the most responsibleindividual onsite at the processingfacility or by a higher level official ofthe company is important for both thehazard analysis and the HACCP plan.The signature reflects the fact thatmanagement has reviewed, accepted,and is responsible for the content of thehazard analysis and any resulting plan.Therefore, the agency concludes thatboth the hazard analysis and anyresulting HACCP plan must be signed.

(Comment 93) One commentsuggested that the final rule shouldallow initialing of records instead of asignature, as is done with low acidcanned foods.

The agency disagrees with thecomment. The food canningestablishment registration and the foodprocess filing form for low acid cannedfoods both require the signature of anauthorized individual. Other low acidcanned food records must be signed orinitialed (§ 113.100). Part 120 hassimilar requirements for juice productrecords. Section 120.12(b)(3) states thatall records shall include the signature orinitials of the person performing theoperation or creating the record.However, given their centrality in aHACCP program, it is important that thehazard analysis and the HACCP plan bereviewed and authorized by the mostresponsible individual onsite at theprocessing facility or by a higher levelofficial of the processor so as to signifythat management of the firm is aware ofand has accepted these records(§ 120.12(c)). Therefore, the agency isnot modifying part 120 to permit theinitialing of the hazard analysis and theHACCP plan.

(Comment 94) One comment arguedthat consumer complaints often involvequality issues and are primarily handledat headquarters facilities, not processingplants. Therefore, the comment statedthat consumer complaint records shouldnot be part of HACCP recordkeepingrequirements.

The agency points out that consumercomplaint records are not required to bemaintained or access given to them

under part 120. Processors are requiredto review consumer complaints as a partof their verification procedures(§ 120.11(a)(1)(i)) to determine whethercomplaints relate to the performance ofthe HACCP plan or to reveal previouslyunidentified hazards. Processors maychoose to include consumer complaintsin their HACCP records to documentverification of the HACCP system, but itis not required.

(Comment 95) One comment statedthat the period that records must beheld is out of line with product shelf lifebecause fresh juice only lasts 14 days.The comment suggested that recordscould be kept for 3 months rather than1 to 2 years.

FDA disagrees with the comment.Some problems, such as trends in thefrequency of process deviations, maynot be easily recognized in a ‘‘snapshot’’record review. By reviewing recordscovering a longer period of time, aprocessor may be able to identify certainprocess deviations. Moreover, while itmay be true that most fresh productswill be unusable within 3 months, someproducts are processed for longer shelf-life (such as flash pasteurized,refrigerated juices), and retention timesof less than 1 year do not provide forsufficient information for theprocessor’s or FDA’s verificationactivities. (See § 120.11(b).) Therefore,FDA has made no changes to§ 120.12(d)(1).

(Comment 96) One commentrequested that FDA revise § 120.12(d)(1)to read ‘‘Subject to part § 120.14, allrecords required by this part * * *,’’because there are other importerrequirements for recordkeeping outlinedin § 120.14.

The agency disagrees with thecomment. Section 120.12(d)(1) requiresboth processors and importers to retainall records required by part 120. Under§ 120.12(d)(1), importers must retain therecords required under § 120.14 at theimporter’s place of business in theUnited States. Therefore, the agencyconcludes that the modification is notnecessary.

(Comment 97) One comment notedthat proposed § 120.12(d)(2) requiresprocessors to maintain records related tothe adequacy of equipment or processes.The comment stated that if equipment isold or modifications have been made toit, firms may have trouble getting a letterto that effect from the manufacturer.Therefore, the comment stated,scientific studies will have to beperformed to determine adequacy,which will be costly, especially forsmall processors. The comment statedthat the requirement is not consistentwith parts 113 and 114. It stated that a

written communication summarizingrequirements to achieve an adequateprocess would be adequate.

FDA has reevaluated the provision in§ 120.12(d)(2) and concludes that it doesnot afford any additional significantprotection to consumers and may addunnecessary burdens for processors.Therefore, the agency is deleting§ 120.12(d)(2) and recodifyingparagraphs § 120.12(d)(3) and (d)(4) as§ 120.12(d)(2) and (d)(3), respectively.

(Comment 98) One commentsuggested that FDA restrictrecordkeeping requirements to recordsproduced at the manufacturing facility.The comment stated that data used toestablish processes should bemaintained by the individual ororganization that developed the record,not by the processing plant.

FDA disagrees with the comment. It isvital that each processing plantmaintain or have access to all recordsrequired under part 120, that pertain toproducts produced by that plant forpurposes of both processor review andFDA inspections. The agency has madeprovision for offsite storage of records,to the extent feasible, to reduce plantstorage burden. Specifically, under§ 120.12(d)(2), electronic records areconsidered to be onsite if they areaccessible from an onsite location andcomply with § 120.12(g). In addition,under § 120.12(d)(2), offsite storage isallowed for certain monitoring recordsafter 6 months following the date thatthe monitoring occurred as long as therecords can be retrieved and providedonsite within 24 hours. Finally, under§ 120.12(d)(3), seasonal processors maystore records at a reasonably accessiblelocation at the end of the seasonal pack.

Records (such as the hazard analysis,HACCP plans, and verification,including validation, records forproducts processed in the plant) areneeded by both the processor and FDAto determine whether the HACCPsystem or systems are properlyimplemented and effective. HACCPsystems and associated records may betailored to each specific processingfacility and for different productsprocessed in the facility. Therefore, theagency concludes that all recordsrequired by part 120 must be retained atthe processing facility to which theyrelate (or reasonably accessible whenoffsite storage is permitted) or at theimporter’s place of business in theUnited States. As discussed in previouscomments, FDA recognizes thatprocessors may review information (e.g.,consumer complaints) to develop/evaluate their systems that is notrequired to be maintained and to whichprocessors are not required to grant FDA



access. Processors may maintain thisinformation at any location that isconvenient for the processor.

(Comment 99) One commentpointed out an inconsistency betweenthe preamble to the proposed rule thatstated that after 6 months the SSOP andHACCP monitoring and correctiveaction records could be stored offsite,and the codified language in proposed§ 120.12(d)(3) that refers to the storageof SSOP records and the HACCP planoffsite.

FDA agrees that the proposal’spreamble and codified wereinconsistent. The agency realizes thatsome juice processors may be requiredto store records that could require agreat deal of space (e.g., the SSOP andHACCP monitoring and correctiveaction records) and that there may notbe adequate storage space in theprocessing facility for all of theserecords. However, because of theirdirect relevance to ensuring safeprocessing operations at a facility, FDAhas concluded that records dealing withthe HACCP plan must remain on site forat least 6 months. After that period,such records may be stored off-site ifthey can be retrieved and returned on-site to the plant within 24 hours so thatplant managers and FDA investigatorshave ready access to the records for usein evaluating the effectiveness of theHACCP plan. Therefore, FDA ismodifying § 120.12(d)(2) to refer toparagraphs (a)(1) and (a)(4) instead of(a)(1) and (a)(3).

(Comment 100) One commentrequested that FDA delete § 120.12(e)because the agency does not have thestatutory authority to see consumercomplaints.

The agency advises that consumercomplaints are not required recordsunder § 120.12(a) and the rule does notseek to require that FDA be given accessto such records. Thus, the agencyconcludes that no action is necessary inresponse to this comment.

(Comment 101) Several commentsexpressed concern about theconfidentiality of records associatedwith an abandoned process. They statedthat a manufacturer’s processingmethods are often considered tradesecret even for products that have beenabandoned. The comments suggestedthat the agency make provisions for thisin the final rule and handle abandonedproduct records in the same manner asexisting product information. Onecomment added that current processlines may use technology similar to thatused for an abandoned product and thatabandoned products may be broughtback into production.

The agency advises that the agencyintended that proposed § 120.12(f) notpermit public disclosure of processingrecords except where they have beenpreviously disclosed to the public orwhere they relate to an abandonedproduct or ingredient and are no longertrade secret or confidential commercialor financial information. FDAacknowledges that the proposal was lessthan clear as to the status of anabandoned product process. To clarifythe final rule, FDA is striking the work‘‘thus’’ from § 120.12(f) so that the tradesecret status of a product process maybe maintained by the processor and theinformation not necessarily subject topublic disclosure even though theparticular product has been abandoned.The public availability of suchinformation will be evaluated by FDAon a case-by-case basis.

(Comment 102) Several commentsrequested that HACCP documents inFDA’s possession not be made availableunder the Freedom of Information Act(FOIA).

FOIA provides consumers and otherswith the opportunity to obtain recordsin the possession of Federal agencies,including FDA, upon request. There are,however, some restrictions on the typesof records available under FOIA. Forexample, confidential commercialinformation and trade secrets areexempt from disclosure 5 U.S.C.552(b)(4). The agency concluded in theseafood HACCP final rule (60 FR 65096at 65138) (Ref. 62), that HACCP plans,as a general rule, meet the definition oftrade secret information, and thus, evenif these plans are in agency files, theylikely would not be available underFOIA. However, because FDA is boundby FOIA and the agency’s implementingregulation in 21 CFR part 20, the agencyis unable to exclude categorically allHACCP records in agency files frompublic disclosure.

J. TrainingThe agency proposed that only

individuals trained in HACCP beresponsible for certain key functions ina HACCP system. The agency iscorrecting an error in § 120.13(a)(3), asproposed, so that the section references§ 120.10(b)(5) instead of § 120.10(c)(5)because there is no paragraph (c)(5).

(Comment 103) Several commentsrequested that FDA provide training forthe juice industry.

FDA has limited resources to use fortraining. Therefore, the agency has noplans at present to provide specificHACCP training for the juice industry.However, the agency is interested incooperating with States and the industryin the development of training

programs. FDA worked with theSeafood Alliance to develop a seafoodHACCP curriculum and trainingcourses. A similar cooperative effortwould be very beneficial in juiceprocessing. Also, the agency is in theprocess of developing a juice HACCPhazards and controls guide, which willassist juice processors in thedevelopment of their HACCP systems.

(Comment 104) One commentquestioned whether the agency willacknowledge the equivalency of juiceHACCP training, as mentioned in§ 120.13(b), offered by other parties(such as a trade association or academicinstitution) as it did for seafood HACCP.The comment asked how and whowould determine training adequacy.Another comment suggested thatequivalency of training programs wouldbe better dealt with by establishingtraining objectives, such as the systemused in meat and poultry HACCP, ratherthan specific materials and curricula.

FDA believes that the development ofseafood HACCP training, through theSeafood Alliance, was beneficial for allparties. A basic curriculum wasdeveloped, which the agency reviewed,that was available for the industry’s use.The agency has encouraged trainers toevaluate their courses against thematerials developed by the Alliance andto make modifications necessary toensure that programs were consistentwith and provided at least an equivalentlevel of instruction to the Alliancecourse. FDA is very interested incooperating with all interested parties,including academia, consumer groups,and the juice industry, to developtraining programs that incorporate themost appropriate objectives andmaterials. FDA will acknowledge theequivalency of training in the samemanner as is done for seafood HACCP.

(Comment 105) One commentargued that criteria for adequate HACCPtraining should be left up to the Statesto determine, but did not provide anysupport for this opinion. The commentalso asked that FDA provide States withguidance and funding to carry outHACCP training for existing Statepersonnel and to certify HACCPspecialists.

The agency currently intends toprovide training to States, throughcontracts and State partnerships. Theagency recognizes that the effectivenessof juice HACCP hinges on consistentimplementation and regulationthroughout the United States andtraining, particularly for investigators,plays an important role in suchconsistency. As noted above, FDA isinterested in cooperative work with



States, academia, and industry todevelop training programs.

(Comment 106) One comment statedthat individual companies should bepermitted to determine whenexperience can substitute for HACCPtraining. Another comment argued thatexperience can never substitute fortraining, although the commentcontained no data or other informationto support the claim.

FDA believes that in certaincircumstances, appropriate jobexperience can be an adequatesubstitute for formal HACCP training.FDA is aware that some juice processorshave had successful HACCP programsin place for a long period of time and,as a result, employees working withthose systems have gained a workingknowledge about HACCP that is morethan adequate to meet the trainingrequirement. Moreover, FDA’sexperience is that other segments of thefood industry have HACCP programs inplace and employee experience gainedworking with those systems may betransferred successfully to juiceprocessing. It is the responsibility ofprocessors to determine that theirHACCP system is functioningappropriately and is in compliance withpart 120, a responsibility that includesensuring that those individuals involvedin designing and implementing theHACCP system are qualified.

(Comment 107) One commentsuggested that FDA develop a test todetermine whether particular jobexperience can substitute for HACCPtraining. The comment asked if FDA isdeveloping such a test.

FDA has no plans to develop a test todetermine whether job experience cansubstitute for HACCP training. Jobexperience that is equivalent to traininggained under an adequate standardizedHACCP curriculum is certainly one waythat individuals may gain the trainingrequired in § 120.13(a). However, asnoted, it is the responsibility ofindividual companies to ensure thatqualified individuals conduct thehazard analysis and develop the HACCPplan, whether such individual isqualified through training or jobexperience.

K. Application of Requirements toImported Products

The agency proposed in § 120.14specific requirements for importers ofjuice products because FDA typicallydoes not inspect foreign foodestablishments. Under § 120.14 of theproposed rule, importers of juice eithermust ensure that all juice offered forentry into the United States has beenprocessed in compliance with part 120

or import such juice from a country thathas an appropriate memorandum ofunderstanding (MOU) with the UnitedStates. In addition, importers mustmaintain records that document theperformance and results of theaffirmative steps taken to demonstratecompliance with § 120.14.

(Comment 108) Several commentscontended that the juice HACCPregulation should not apply to imports.However, other comments disagreed. Afew comments suggested that onlyimported fresh juice be covered, notjuices that have been documented tohave been thermally processed to meetthe 5-log performance standard.

The agency advises that this final rulewill cover all imported and domesticfresh or processed juices. First, underthe act, all products in interstatecommerce, whether imported ordomestic, must adhere to the samestandards. Moreover, imported juicesmay have many of the same potentialfood hazards as domestic products. FDAdiscussed outbreaks associated withimported juices in the proposed rule (63FR 20450 at 20450) (Ref. 2), and someof the recent outbreaks discussed inresponse to comment 26 were associatedwith imported juice (Refs. 46 and 47). Inaddition, imported juices may containfood hazards not normally associatedwith domestic products. The differencesin the types of food hazards may be thefunction of a number of factors,including differences in processingsystems and sources of raw ingredients.The fact that HACCP is based onprevention of specific hazards makes itapplicable, in general, to foodprocessing wherever the processingoccurs. Therefore, the agency agreeswith those comments that stated that therule must apply equally to imported anddomestic juice products, because thepotential risks are the comparable. Thesafety of juice must be ensuredregardless of where it is produced.

(Comment 109) One commentsuggested that FDA clarify the referenceto ‘‘imported food’’ in the introductorysentence of § 120.14 to identify thatjuice is the specifically covered product.

The agency agrees with thissuggestion and has revised theintroductory sentence of § 120.14 byreplacing the word ‘‘food’’ with theword ‘‘juice.’’

L. Process Controls

1. Performance Standard

The agency proposed to require thatjuice processors, except those that aresubject to part 113 or part 114, includein their HACCP plans control measuresthat will produce at least a 5-log (105)

reduction in the pertinentmicroorganism. As proposed, thepertinent microorganism means thepathogen that is likely to occur in juiceand that is most resistant to thepathogen reduction technology usedand, if it occurs, is likely to be of publichealth significance. The proposedreduction must be for a period at leastas long as the shelf life of the productwhen stored under normal andmoderate abuse conditions.

(Comment 110) Several commentsadvocated a regulatory scheme ofHACCP without the performancestandard proposed by FDA. Thecomments argued that a performancestandard is not necessary to ensure thesafety of all products (e.g., citrus).Comments stated that requiring aperformance standard negates thestrength and function of HACCP andindicates that FDA does not trustHACCP alone. The comments assertedthat FDA should require either theperformance standard or HACCP, butnot both.

The agency disagrees that having theperformance standard as an integral partof HACCP weakens the HACCP system.As NACMCF has pointed out, theperformance standard enhances HACCPby establishing the appropriate level ofhealth protection that must be achieved(Ref. 25). The 5-log reductionperformance standard assures publichealth protection for consumers andassists processors by establishing aminimum microbial standard for safejuice. Particularly for non-heat treatedjuice, the 5-log reduction requirementprovides a standard against whichprocessors can measure theeffectiveness of combinations of HACCPcontrols. Including a performancestandard as part of HACCP sets a goalfor processors without mandating themeans by which they must achieve thatgoal and also provides a means ofdetermining the equivalence ofalternative strategies for controllingpathogens. Finally, FDA disagrees withthe suggestion that a performancestandard alone will ensure safe juice. Asnoted previously, there are hazards inaddition to microbial contamination,and a performance standard alone doesnot address the chemical and physicalhazards that may be present in juice.

(Comment 111) Many commentsstated that the final rule should identifya safety goal instead of a performancestandard and let industry decide how tomeet it.

FDA points out that the performancestandard in § 120.24 is a microbialsafety goal and that the final rule allowsthe industry to decide how to achievethe safety goal. Elsewhere in this



preamble, FDA has included guidanceon the application of the 5-log standard,and FDA also intends to issue a juiceHACCP hazards and controls guidance.Both of these forms of guidance areavailable to the juice industry to help indeciding how to achieve the safety goal.Therefore, the agency concludes that nomodification is necessary in response tothis comment.

(Comment 112) A few commentssuggested that producers who do notuse dropped fruit should be able to useHACCP without a performancestandard. One comment contended thata 5-log reduction is not necessary whenthe source of the fruit is known andprocessors follow CGMP’s.

This comment did not provideevidence to persuade FDA that usingtree-picked fruit, along with HACCP,would make the 5-log performancestandard unnecessary. In fact, produce,in general, including tree picked fruit,may not be pathogen free. Agriculturalwater, birds, insects, and harvesters arevectors that can potentially contaminateproduce even though the produce hasnot come into contact with the ground.Even if pathogens are present on or inthe produce used to make juice,processors can make safe juice byattaining the 5-log reductionperformance standard.

(Comment 113) Many commentsstated that the 5-log performancestandard was not appropriate becauseprocessors would have to pasteurizetheir juice to meet the standard. A fewcomments stated that the 5-logperformance standard is unreasonable,counterproductive, and precludesconsideration of harvesting and farmingpractices that help ensure safety.

The agency disagrees with thecomments. The performance standard in§ 120.24 allows for the use of alternativetechnologies. The basis for 5-log isdiscussed in response to comment 124.As noted in section III.L.4, applicationof 5-log must occur where the treatmenthas direct contact with any and allpathogens that may be present. For mostjuices, this will entail direct treatmentof the juice after extraction. For citrusjuice only, the available data andinformation show that surfacetreatments can be used to meet all orpart of the performance standard. Ineither case, treatments should beapplied at a single location under theprocessor’s control and immediatelybefore packaging, in order to preventpost-process contamination of the juice.Although fruit producers and juicemanufacturers are encouraged to followGAP’s, GAP’s such as water and manuremanagement are generally aimed atminimizing the potential for

contamination rather than eliminatingpathogens that may be present. Thus,use of GAP’s would not be a substitutefor the 5-log reduction treatment.

(Comment 114) A few commentssuggested that, in addition to the 5-logreduction performance standard,producers should be given the optionthat Food Safety and Inspection Service(FSIS) gives for fermented sausage,which is batch testing to determine thatthe product contains less than a certainlevel of pertinent pathogens and thenuse a 2-log reduction on the batchtested.

FDA disagrees with the comments’suggestion. Juice is significantlydifferent from a fermented meat productin that a fermented meat product istypically inoculated with bacterialcultures as part of the productionprocess. The growth of the addedmicroorganisms modifies the foodenvironment so that pathogenic bacteriaare inhibited or inactivated; there is nocomparable inoculation and inhibitionactivity with juice. Moreover, thisprocess occurs over an extended periodof time (3 to 6 weeks is common), whichallows time for test results to becompleted. Juice, especially juice that isminimally processed, must be processedand consumed within a significantlyshorter period than fermented productsand, thus, extensive microbial testing offinished, processed products is notpractical. Therefore, because there is nocounterpart in juice processing to theinhibition or inactivation of pathogensby an added bacterial culture, theagency concludes that batch testing toestablish that juice contains a minimumlevel of pertinent pathogens followed bya 2-log reduction in the pertinentpathogen is not an appropriatesubstitute for the 5-log reductionperformance standard.

(Comment 115) Several commentsmaintained that there are no data toshow that certain combinations ofpreventive steps are not adequate toensure juice safety. One commentargued that a combination of grading,washing, sanitation, and currentextraction techniques are sufficient tomeet the 5-log reduction.

FDA is not prohibiting the use ofappropriate cumulative controls toattain the 5-log reduction for citrusproducts. However, as discussed insection III.L.4, FDA has determined thatthe 5-log reduction must occur wherethe treatment has direct contact with allpathogens, if they are present. Further,cumulative controls must be completedin a single production facility under thecontrol of the processor, be effectiveagainst the pertinent pathogen, bevalidated, and be vigorously

implemented to ensure that the full 5-log reduction is consistently achievedunder commercial processingconditions. GAP’s and CGMP’s that donot meet these criteria would be inaddition to, but not count as part of, the5-log reduction. The agency notes that itis the responsibility of the processor todemonstrate that combinations ofpreventive steps are adequate to achievethe 5-log pathogen reduction standard.

(Comment 116) A few commentsexpressed concern that no attention wasbeing given to preventing the presenceof pathogens in juice.

Prevention of pathogens in juice is thereason HACCP was proposed and isbeing finalized. The agency has alwaystaken the position that food safety isenhanced by the use of the highestquality incoming materials. The agencystrongly encourages growers toimplement preventive controls and hasissued GAP guidance to assist growersin the production of safe produce thatis not contaminated. FDA is issuing part120 to assist processors in establishingpreventive controls. Specifically,§ 120.7(b) provides that the hazardanalysis shall include hazards that canbe introduced both within and outsidethe processing plant environment,including hazards that can occur before,during, and after harvest. In addition,§ 120.7(d) requires that processorsevaluate product ingredients todetermine their potential effect on thesafety of the finished food.

(Comment 117) One commentrequested that FDA explain how theperformance standard applies to eachdifferent juice (apple, citrus, vegetable,and blends).

FDA advises that the performancestandard in § 120.24 applies to all juice,including blends of more than one typeof juice. Processes for attaining a 5-logreduction will vary significantlydepending on the target pathogen andthe type of juice produced. Therefore, itis up to each processor to determinehow best to apply the performancestandard to its process. FDA intends todevelop a juice HACCP hazards andcontrols guidance for juice that willprovide processors information on theapplication of the performance standardin addition to that provided in this finalrule. The scientific literature is anothersource of information for processors onrecent developments to attain the 5-logreduction for various types of fruits andvegetable juices. Guidance documentsfrom State agencies may also provideinformation.

(Comment 118) One commentsuggested that all processors should berequired to meet the chosenperformance standard the same way.



The agency disagrees with thecomment. FDA specifically chose not tomandate that processors use a particularmethod to meet the performancestandard in order to provide flexibilityand to encourage innovation. Differentmethods that have been validated tomeet the 5-log reduction standard canbe effective in controlling pathogens tothe appropriate level, which is the goalof the performance standard. Mandatinga specific technology for processors touse would eliminate the incentive forprocessors to develop new and possiblyimproved alternative methods. FDAdoes not want to limit innovativeapproaches to achieving food safety orthe flexibility for processors to choosethe most appropriate method for aparticular operation.

(Comment 119) Some commentsrequested a zero tolerance for E. coliO157:H7 in juice. One comment wasconcerned that the NACMCF may haverecommended a higher threshold of riskthan consumers would consideracceptable. It stated that there is noacceptable level of risk with regards toE. coli O157:H7 because it is so virulentthat a single organism could be deadly.The comment sought scientific evidencethat the 5-log performance standard willtruly kill these organisms, as opposed torepresent a reasonable number oforganisms killed.

The agency disagrees with thecomments. FDA notes that no foodprocessing method can be shownscientifically to achieve a ‘‘zero’’ levelfor a pathogen or any other contaminantpotentially present in the processedfood due to the detection limits of therelevant analytical methods. Forexample, the methods used to detect E.coli in juice in several State surveys hada detection limit of < 1 cell per 3.33milliliter (mL) juice. Thus, a negativeresult does not necessarily mean thatthe microorganism is not present, justthat it is not present at detectable levels.Furthermore, if pathogens are notdistributed homogeneously throughouta product, they may be present in theproduct but not in the sample tested.Conversely, food processing methodscan be shown scientifically to reduce,by mathematical increments (i.e., by‘‘logs’’), the level of pathogens that maybe present in juice and, as a result, toreduce the risk of illness from juice.FDA has received no comments toundermine the assumption based on theNACMCF recommendation that the 5-log performance standard willadequately protect consumers from E.coli O157:H7 and other pathogens.

(Comment 120) One commentcontended that a 5-log performancestandard is unenforceable and that FDA

should set pathogen reduction goalssimilar to those established for meat andpoultry.

FDA disagrees that the 5-logperformance standard is unenforceable.The reasons FDA did not set a zerotolerance for pathogens, as was done forcertain pathogens in meat and poultry,already have been discussed in theresponse to comment 114. By virtue ofthe requirements of part 120, FDAbelieves that the performance standardis enforceable. That is, as part of theirHACCP plan, processors must have avalidated procedure for achieving a 5-log reduction in the pertinent pathogenfor their process and also must havedocumentation to demonstrate to FDAthat the standard is being achieved.Processors who cannot meet theserequirements will not be in compliancewith part 120 and thus, will be subjectto regulatory action.

(Comment 121) A few commentssuggested that FDA use ‘‘safe harbor’’guidelines rather than require the 5-logreduction to ensure juice safety.

The comment did not define the term‘‘safe harbor.’’ FDA assumes, however,that by ‘‘safe harbor’’, the commentmeans that FDA would provideguidance, such as times andtemperatures for thermal treatments,that, if complied with, would bedeemed to achieve the 5-log reduction,thus providing a basis to conclude thatthe processor is in compliance with§ 120.24. FDA is currently working withindustry to develop guidance on how toachieve the 5-log reduction, and hasalready met with the apple industry andcitrus juice industry to discusstechnological options for achieving theperformance standard. Although theagency is developing guidance to assistprocessors in achieving the 5-logreduction, FDA does not intend suchguidance to provide a ‘‘safe harbor’’.Thus, juice processors will not beabsolved from adopting HACCP anddemonstrating through validation andverification that they have met theperformance standard.

(Comment 122) One comment notedthe statement in the agency’s PRIAstatement (63 FR 24254 at 24264) (Ref.6) that other methods of meeting theperformance standard may not be aseffective as pasteurization or prevent asmuch illness seems to indicate anagency lack of confidence in methodsother than pasteurization.

FDA disagrees with the interpretationof the PRIA statement. The statementreferenced from the PRIA reads ‘‘To theextent that processors adopt controls forthese hazards other than flashpasteurization which are less effective,the percentage of cases prevented may

be smaller than those estimated here.’’The benefits of the rule with regard toillness prevention were developedbased on the amount of illness thatwould be prevented if all juices werepasteurized because, at the time theproposal was published, pasteurizationwas the primary effective, commerciallyimplemented method for controllingpathogens in juice that had beenvalidated to meet the performancestandard. Since the publication of theproposal, it has become evident thatthere may be methods other thanpasteurization, some of which mayrequire FDA approval for their use, thatcould be used to treat juice (e.g., use ofUV irradiation, high pressure). While itis true that pasteurization treatmentssignificantly exceed the 5-log pathogenreduction performance standard, thestatement in the PRIA was not intendedto imply that methods other thanpasteurization are not effective atpreventing illness or that these othermethods cannot meet the 5-logreduction performance standard.

(Comment 123) One comment notedthat pasteurization would add acomplicated and unnecessary step tocider production that will take time andrequire documentation.

FDA is not requiring in thisrulemaking that juice be pasteurized.This rulemaking requires that juice beprocessed under a HACCP system thatcontains a control or controls that havebeen validated to achieve a 5-logreduction in the target pathogen. A juiceprocessor may choose to meet the 5-logreduction requirement by pasteurizingproduct or by any other validatedmeans. Although pasteurization is theprimary option available for cider at thistime, this final rule does not precludethe development or use of alternativetechnologies to achieve a 5-logreduction. For example, FDA recentlyamended the food additive regulationsto provide for the safe use of ultraviolet(UV) irradiation to reduce humanpathogens and other microorganisms injuice products (65 FR 71056, November29, 2000) (Ref. 75). Importantly,however, the processor chooses to meetthe 5-log reduction requirement, theprocess utilized by the processor mustbe validated and verified as achieving a5-log reduction in the pertinentmicroorganism. The risks associatedwith consumption of cider and otherjuices are well established (see 63 FR20450 (Ref. 2) and section II.C of thisfinal rule) and justify regulatoryrequirements that processors establishcontrols for pathogens and the otherhazards associated with juice.



2. Magnitude of Reduction

(Comment 124) Many commentsquestioned the scientific basis for the5-log reduction performance standard. Afew comments contended that it was toostringent based on actual numbers ofubiquitous coliform bacteria found incider in State surveys. In support, asurvey submitted as part of a commentquestioning the basis of a 5-logreduction standard showed that samplesof apples in cider mills in Marylandcontained an average of only 3-logs ofubiquitous coliform bacteria and nogeneric E. coli or E. coli O157:H7. Somecomments asserted that a 5-logperformance standard is prematureconsidering that the source of E. coliO157:H7 contamination in apple juice isnot known and suggested that FDAadopt a 3-log performance standarduntil scientific data are developed tosupport the need for a 5-log standard.The comments stated that without datato provide baseline numbers forcontamination of juice, any performancestandard selected might beinappropriately stringent or lax. Thecomments maintained that the 5-logstandard is particularly excessive if aprocessor is using CGMP’s and onlyuses prime fruit.

Conversely, one comment suggestedthat the 7-log performance standardused by other high risk food processorswould afford more consumer protection.It suggested that the agency compare theprotection offered by 5, 6, and 7 logperformance standards because E. colikeeps proving to be more resistant tocontrols than previously thought andbecause a 5-log reduction may not beadequate for all strains of E. coli.

FDA discussed the cider surveyresults in the response to comment 36.In that discussion, the agency noted thelimitations of the analytical methodsand advised that the survey results didin fact affirm that risk factors such asfecal coliforms, an indicator of thepossible presence of pathogens, arepresent in cider operations and couldgive rise to microbial food safetyhazards in the finished juice.

In establishing the 5-log standard,FDA is relying on the advice of a panelof recognized food safety experts, theNACMCF. In making thisrecommendation, the Fresh ProduceWorking Group of the NACMCFconsidered various situations that couldoccur with juice (Ref. 63). First, theyconsidered what levels of E. coli mighttypically occur in juice and added astandard 100-fold safety margin. TheWorking Group then considered a worstcase scenario where produce could becontaminated with bovine feces, a

source of E. coli O157:H7. Theydetermined that a 5-log reduction wouldboth eliminate the E. coli O157:H7contamination and provide a safetymargin. In addition to the informationfactored into determination of the 5-logreduction performance standard,regulatory precedents were considered.The 5-log pathogen reductionperformance standard is used by FDAfor Salmonella inactivation for in-shellegg pasteurization and by FSIS forinactivation of E. coli O157:H7 infermented sausage. The agency hasevaluated the NACMCF advice andconcluded that the 5-log performancestandard recommended by the NACMCFis the most appropriate standard toensure that juice is safe.

This pathogen reduction performancestandard, in combination with therequirement that measurement of the5-log reduction begins after cleaningand culling of citrus fruits and, for allother juices, when the treatment hasdirect contact with any pathogens in thejuice (discussed in the response tocomment 131), provides adequatepublic health assurance whileminimizing the impact of treatments onthe sensory attributes of the juices (Ref.64). While a 3-log reduction could beadequate under certain circumstances, itdoes not ensure that juice is safe underall circumstances that may occur. Incontrast, the 5-log reductionperformance standard has a built-insafety factor that provides additionalconsumer protection.

In light of the comments, FDA hasconsidered a 6- or 7-log reductionstandard and concluded this additionallevel of reduction is not necessary tocompensate for possible futuremicrobial resistance. The 5-logreduction refers to numbers ofmicroorganisms, not resistance ofmicroorganisms. Strains ofmicroorganisms may become moreresistant to heat, acid, sanitizers or othercontrols over time. Becausemicroorganisms are capable ofdeveloping resistance, it is critical thatjuice processors periodically verify andvalidate their process to determine thecontinued effectiveness of the process. Ifresistance occurs, processors may needto make appropriate changes in theirprocess so that their process continuesto attain a 5-log reduction in pathogens.Therefore, the agency concludes thatincreasing the performance standard toattain a greater log reduction is notnecessary to compensate for possiblefuture increased resistance of pathogens.

(Comment 125) One commentasserted that a 1000-fold safety factor isnot consistent with other performancestandards set by FDA, although the

comment did not reference any specificperformance standards. The commentmaintained that a performance standardshould be based on actual levels ofpathogens found in or on fruit plus a 1-or 2-log safety factor.

FDA has concluded that the 5-logperformance standard recommended bythe NACMCF is the most appropriatestandard to assure that juice is safe. Inthe response to comment 124, FDAdiscussed how the Fresh ProduceWorking Group of the NACMCF arrivedat the 5-log pathogen reductionperformance standard. Thisperformance standard includes thecustomary 100-fold safety factor, not a1,000-fold safety factor as asserted bythe comment. Therefore, the agencyconcludes that the 5-log value isconsistent with other performancestandards set by FDA and, in fact, wasarrived at using the 100-fold (2 log)safety factor the comment suggested.

(Comment 126) Several commentsstated that 5-log is not an appropriateperformance standard for citrus juicebecause, in trial studies, researchershave not been able to inoculate fruitwith sufficient numbers ofmicroorganisms to measure a 5-logreduction. One comment stated thatminimum safety performance criteriashould be established for citrus becausethe likelihood of contamination in citrusjuices is not high. However, anothercomment suggested that a 5-logperformance standard would beappropriate for orange juice because itcan be attained without heat and a 3-logperformance standard would beappropriate for apple juice because thismay be the maximum attainable withoutheat treatment.

FDA proposed the 5-log performancestandard based on safety considerationsand on the recommendation of theNACMCF (Ref. 63). As mentioned in theresponse to comment 124, while a 3-logreduction could be adequate undercertain circumstances to ensure thatjuice is safe, the 5-log performancestandard has a 2-log safety factor thatoffers additional consumer protection.In addition, the agency found in itsreview of performance criteria for otherfoods, that a 5-log reduction inpathogens is the standard for productsafety in several cases (Ref. 63).Although the target pathogen may differamong juice types and, thus, change thespecific processing parameters (e.g.,temperature, processing time) forattaining a 5-log reduction, FDAmaintains that the 5-log performancestandard is appropriate for all juices.The one area where FDA has data tosuggest differences between citrus juiceand other juices is with respect to the



potential for pathogen infiltration.Specifically, the available data showthat the potential internalization ofpathogens in sound, intact citrus fruit isnot likely to present a significant publichealth risk (see the response to 132).Thus, for citrus juice only, the agencyhas determined that surface treatmentsmay be used to achieve the 5-logreduction standard. Accordingly, citrusjuice processors have an additionaloption in how to achieve theperformance standard (i.e., 5-logreduction), but the standard is the same.

FDA also rejects the comment’simplicit suggestion that the performancestandard should be based on what istechnically feasible. In order to assuresafe food, a performance standard mustbe based on safety, not on whether it isattainable using only certaintechnologies, such as heat treatment.Presenters at the Florida and CaliforniaFDA workshops on the 5-log pathogenreduction (November 12, 1998 andNovember 19, 1998) and FDA researchpresented at the December 8 to 10, 1999,NACMCF meeting demonstrated thatresearchers could and had inoculatedfruit with pathogens to a level thatpermits measurement of a 5-logreduction. Therefore, FDA is notpersuaded that the performancestandard should be different fordifferent produce used to make juice.

(Comment 127) Several commentsnoted that the 5-log performancestandard was chosen by NACMCF andthat there was no representative of thefresh juice industry on the Committee.The comments maintained thatNACMCF may not have consideredwritten comments that were submittedafter the public meeting when makingits recommendation.

The NACMCF based itsrecommendation for a 5-logperformance standard for juice on safetyconsiderations, which included ascientific evaluation and rationale for a5-log reduction standard. FDA reviewedthe advice from NACMCF and chose topropose the same standard for HACCPsystems for juice because the agencydetermined that the 5-log standard issupported scientifically. The structureof the NACMCF and the way itfunctions allow for public commentduring the meeting, which commentsthe Committee considers in developingits recommendations. The fresh juiceindustry presented their views to theNACMCF during the meeting inquestion. FDA, on the other hand,typically announces a period of timeduring which comments related to thepublic NACMCF meeting may besubmitted. In reaching its conclusion topropose a 5-log reduction standard, the

agency considered written comments,including comments submitted after themeeting, on the appropriateness of the5-log reduction standard, along withcomments presented at the NACMCFmeetings and the NACMCFrecommendations.

(Comment 128) A few commentsrequested that FDA not require smallproducers to meet the 5-log performancestandard until alternatives topasteurization are validated. Thecomments argued that pasteurization istoo costly for small producers.

The agency understands the smallprocessors’ concerns. However, the5-log reduction is based on safety, andtherefore, processors must meet thestandard in § 120.24, in their HACCPsystems in order for public health to beprotected. FDA has documentedoutbreaks that have been attributed tosmall processors (Ref. 65). Inrecognition of the circumstances ofsmall processors, however, the agency isestablishing staggered compliance datessuch that there is an additional 1 yearfor small processors and an additional 2years for very small processors tocomply with the HACCP final rule.Importantly, such processors must usethe label warning statement if they arenot processing their product to achievethe 5-log reduction. FDA believes thatthis approach does not substantiallycompromise safety and at the same timeprovides accommodation to small andvery small processors. Therefore, theagency declines to modify the regulationto exempt small producers from the5-log performance standard.

3. Pertinent Pathogens(Comment 129) Some comments

provided views on the types ofmicroorganisms that should beconsidered the pertinent microorganismfor measuring the 5-log reduction. Onecomment contended that the chosentarget organism must make scientificsense based on their extremes ofpathogenic viability across multiplereduction steps. A few comments statedthat Listeria monocytogenes should notbe a target pathogen for the performancestandard because there is no history ofproblems with Listeria in juice.However, other comments stated that E.coli O157:H7 and L. monocytogenes areboth appropriate target pathogens,especially because Listeriacontamination is a risk to pregnantwomen. One comment also stated thatSalmonella is not an appropriate targetmicroorganism because it is not as acid-resistant as E. coli O157:H7.

FDA has concluded that targetpathogens must be chosen on the basisof historical association with a product

and the way in which the product isprocessed. For example, there have beenapple juice outbreaks associated with E.coli O157:H7, Salmonella spp., andCryptosporidium parvum. Salmonellaspecies have been associated withoutbreaks from orange juice. TheNACMCF recommended the use of E.coli O157:H7 or Listeria monocytogenesas the target organism, as appropriate.This recommendation is based on thenumber of known outbreaks of E. coliO157:H7 in juice and the ubiquitousnature of L. monocytogenes. FDAadvises that if L. monocytogenesbecomes a source of outbreaks in thefuture, especially affecting pregnantwomen, then processors must considerwhether L. monocytogenes should serveas the pertinent microorganism for theirproduct.

Processors must also consider themanner in which they are achieving the5-log reduction and the microbialresistance to the process. For example,a new technology may be effective inattaining a 5-log reduction of E. coliO157:H7 in apple juice, but may allowthe survival of Cryptosporidium. E. coliO157:H7 is known to be unusually acid-resistant and L. monocytogenes isrelatively heat-resistant. The 5-logpathogen reduction standard applies tothe most resistant microorganism ofconcern under the processingconditions used. If the microorganism isresistant to a particular treatment andthe treatment does not therefore delivera 5-log reduction in the microorganism,then, obviously, the 5-log reductionstandard has not been met. FDA plansto provide additional information in itsJuice HACCP hazards and controlsguidance to assist producers inidentifying the pertinent microorganismfor measuring the 5-log standard.

(Comment 130) Several commentsrequested that FDA clarify howsurrogate microorganisms should bechosen to validate cumulative stepsused to achieve a 5-log reduction (e.g.,use of sanitizers). One commentrequested that FDA require industry touse an agreed upon ‘‘cocktail’’ ofsurrogates to validate processes.

FDA advises that surrogates should beequally or more resistant to theprocessing conditions than is the targetpathogen to assure that the process alsodestroys the pathogen. As noted in theresponse to comment 129, one treatmentmay be effective in reducing one type ofpathogen but have less or no effect onanother. FDA will be providingadditional guidance on the selectionand effective use of surrogatemicroorganisms for process validationin its juice HACCP hazards and controlsguidance. FDA believes that it is the



responsibility of the producer tovalidate the processes it chooses to usein manufacturing juice products,including determining appropriatesurrogate microorganisms. Therefore,FDA is not requiring use of a ‘‘cocktail’’of surrogates to validate processes.

In choosing and using surrogates, it isimportant to remember that acumulative 5-log reduction must beachieved. Therefore, a processor musthave evidence that there is a totalreduction of 5 logs in the surrogatepopulation and that the same 1- or 2-logreduction is not being countedrepeatedly. In other words, if one stepreduces the surrogate by 2 logs, the nextstep must reduce the surrogate by anadditional number of microorganisms.In addition, care must be taken thatthere is no growth of microorganismsbetween steps.

4. Application of the PerformanceStandard

(Comment 131) Several commentsmaintained that, because of thepossibility that pathogens may becomeinternalized into fruit (or vegetables),the treatment(s) will need to be appliedafter the juice has been extracted so thatthe treatment has intimate (i.e., direct)contact with pathogens. One commentsuggested that FDA require at least partof the treatment be applied directly tothe juice. Conversely, another commentmaintained that, except for warm applesin cold water, the potential for pathogeninfiltration is hypothetical. Even then,according to the comment, use ofpotable water and hygienicallymaintained tanks could controlpathogen internalization despite atemperature differential that couldcause water to be pulled into the fruit.

As stated previously, FDA believesthat, for all fruits and vegetables, thepathogen reduction control processmust begin at the point where thepathogen reduction treatment directlycontacts the pathogens. Inherent in theNACMCF recommendation of the5-log pathogen reduction standard wasthe assumption that the treatment(s)would be applied in a way that wouldeffectively reduce the entire populationof the microorganism of concern by 5-log. In making this recommendation,NACMCF did not contemplatetreatments that may eliminate somepathogens while not reaching others, aswould be the case for surface treatmentof produce susceptible to pathogeninternalization. In fact, the NACMCFspecifically advised that surfacetreatments would have little effect onpathogens if they are internalized.

Contrary to the comment, thepotential for infiltration is not

hypothetical because information anddata from the scientific literaturedemonstrate that, under certainconditions, microorganisms can becomeinternalized. (Refs. 13 and 14) Suchinternalization may occur throughnatural plant structures or throughdecayed or damaged sites on the fruit orvegetable. Water, insects, and birds, allof which may carry human pathogens,can serve as pathogen vectors, resultingin contamination of fruits andvegetables. Internalization may occurbefore or after harvest althoughsubmerging warm harvested fruit incold water (such as dump tanks andflumes) increases the potential forinfiltration into susceptible produce.Similarly, exposing vulnerable externalpoints of fruit or vegetables may alsocause water to be taken-up along withpathogens if they are present.Accordingly, for most fruits andvegetables, this means that the pathogenreduction treatment must be applied tothe juice after extraction. Moreover,processors should include in theirHACCP plans, where appropriate,precautions to avoid or minimize thepotential for infiltration (such as byavoiding submerging warm fruit incolder water). In addition, whileCGMP’s and SSOP’s, such as usingpotable water and sanitary operatingconditions during washing, are a basefor HACCP, they will not necessarilyprevent or correct pathogen infiltrationinto fruits and vegetables. If pathogenshave become internalized in fruit orvegetables, wash treatments, even ifconducted consistent with CGMP’s, willnot eliminate them.

In the case of citrus fruits, FDAconsidered in the preamble to theproposed rule that the structure of citrusfruits prevented internalization ofmicroorganisms, and thus, for citrusfruits, pathogenic microorganisms arelikely to be restricted to the surface ofthe fruit. As such, FDA tentativelyconcluded that surface treatments ofcitrus fruit would satisfy the criterionfor direct contact with all pathogens andcould, therefore, be counted towards the5-log reduction standard (see also theresponse to comment 132).

In response to comments challengingthis agency conclusion and in theabsence of scientific studies directly onthis topic, FDA conducted two studiesto determine the validity of itsassumption, and made the resultsavailable for public comment. Theresults of one study provided evidencethat internalization, survival, andgrowth of human bacterial pathogensmay occur inside oranges. The results ofthe second study demonstrated thatthere is uptake of water by oranges and

grapefruit when there is a transitorypressure differential between theinterior and exterior of the fruit. At theDecember 1999 NACMCF meeting, FDAasked the NACMCF to consider thepotential for internalization ofmicroorganisms by citrus fruits. TheNACMCF concluded that it istheoretically possible formicroorganisms to internalize in sound,intact citrus fruit under conditionswhere a temperature differentialbetween fruit and wash water may causewater to be drawn into the fruit. TheCommittee stated that while this wasdemonstrated in laboratory conditions,the probability of its actual occurrenceunder current industry practices wasnot demonstrated. Accordingly, theNACMCF concluded, based on theavailable evidence, that the potentialinternalization and survival ofpathogens in sound, intact citrus fruit isnot likely to present a significant publichealth risk.

FDA agrees with the NACMCFconclusion. Importantly, the commentsdid not provide any data for FDA toconclude otherwise. Thus, the agency isrequiring in § 120.24 that the 5-logstandard be met by treatments applieddirectly to the juice, except that citrusjuice processors may use treatments tofruit surfaces, provided the 5-logreduction process for citrus begins aftercleaning and culling and isaccomplished in a single productionfacility under the control of theprocessor. (The terms ‘‘cleaning’’ and‘‘culling’’ are discussed below in theresponse to comment 132.)

At the present time, FDA believes thatonly citrus fruits have beendemonstrated to be adequatelyimpervious to internal contaminationsuch that it is reasonable to rely onsurface treatments of these fruits, andtherefore, use of surface treatments toachieve all or part of the required 5-logpathogen reduction is restricted to citrusfruit. Whenever sufficient scientific dataare provided to the agency to establishthat, for other fruits and vegetables, it isappropriate to begin the 5-log reductionprocess at other points than theextracted juice or that establish thatsurface treatment is no longer anacceptable method to contribute to the5-log reduction for citrus fruit, FDA willreview this conclusion.

(Comment 132) A number ofcomments contained suggestions orasked for clarification about where tostart treatment for purposes ofcalculating the 5-log pathogenreduction. A few comments maintainedthat processors grading fruit to reducepotential contamination, and processorsusing other best management practices,



should be able to count these practicestowards the 5-log reduction standard.One comment claimed that FDA shouldallow the measuring of pathogenreduction to begin prior to processing toachieve and count reductions inpathogens from proven sources, such asby cleaning and culling dirty ordamaged fruit. Another commentmaintained that a 2-log reduction ispossible from using tree picked applesinstead of drops and that this practice(i.e., excluding drops) should becounted towards achieving the 5-logreduction.

In contrast, several comments statedthat the earliest possible point to startcounting the 5-log reduction is withclean, sound fruit. One commentmaintained that, while overtly damagedfruit carry a greater risk ofcontamination, apparently sound fruitmay also be contaminated and that,therefore, culling is not a screen formicrobial contamination.

FDA agrees that food safety isenhanced by the highest qualityincoming materials. However, as notedin response to comment 112, FDA doesnot believe that GAP’s (such as usingtree picked fruit) or CGMP’s (such aswashing and culling fruit) are areplacement for the 5-log reduction. Norcan these practices substitute for aportion of the 5-log treatment.Establishment of the 5-log pathogenreduction standard as adequate publichealth protection was based uponcertain starting conditions, includingcleaning and culling the produce, andthe principal that the pathogenreduction treatment must directlycontact the microbiological hazard. Asnoted, for juice made from fruits andvegetables in which there is a potentialfor pathogen infiltration, such contact islikely to occur only after the juice hasbeen extracted; for citrus, wherepathogen internalization is unlikelyunder current industry conditions, the5-log reduction process does not need tostart with the extracted juice but maybegin with exterior decontamination offruit after cleaning and culling.

FDA is defining in § 123.3(a) and (f)the terms ‘‘cleaned’’ and ‘‘culled’’ asdescribed by NACMCF to establish thestarting point for surface treatments forcitrus. Cleaned means washed withwater of adequate sanitary quality.Culled means separation of damagedfruit from undamaged. For processors ofcitrus juices using treatments to fruitsurfaces to comply with § 120.24, culledmeans undamaged, tree-picked fruit(i.e., USDA choice or higher quality).For all juices, cleaning and cullingoperations would be part of CGMP’s,and fruit being tree-picked is not

applicable to the 5-log reduction. This isconsistent with the NACMCFrecommendation that cleaning andculling of citrus fruits not be consideredpart of the 5-log reduction of pathogens.The agency notes that all produce usedfor making juice must be cleaned andculled prior to the start of the 5-logreduction according to CGMP’s.However, FDA is defining these terms toclearly set forth the basic startingconditions for the 5-log reduction,especially in regard to surface treatedcitrus.

(Comment 133) One commentsuggested developing a standard forfruit for juicing that includes nodropped fruit, no blemishes or dimples,and rinsing with pathogen-free water.The comment suggested that beginningwith fruit of a standardized qualitywould not count toward the 5-logreduction, but would ensure that allprocessors start with fruit of the samehigh quality. One comment argued thattreatments that can achieve a 5-logreduction in pathogens when applied tosound, clean fruit may be adequate forproducing safe product but questionedwhether a greater reduction might benecessary if starting with fruit that wasdirty or damaged.

FDA is not setting a standard for fruitquality or expressly prohibiting the useof drops in most juices. As with anyfood, FDA encourages the highestpossible quality incoming materials inthe production of juice. The ProduceWorking Group of the NACMCF arrivedat the 5-log reduction recommendationby considering a ‘‘worse case’’ scenariowhere fruit was heavily contaminatedwith feces, as might occur with the useof drops. The Committee concluded thata 5-log reduction treatment wouldeliminate pathogens and provide a 100-fold safety margin. Thus, FDAconcludes that the 5-log reductionapplied directly to the juice willeliminate pathogens that may otherwisebe introduced by the use of drops. FDAcautions, however, that juice producersthat are exempt from or that have notyet adopted HACCP, including the 5-logreduction standard, can reduce theirrisk of producing contaminated productby avoiding drops and by culling treepicked fruit before extraction.

The agency is establishing a standardfor citrus fruit that is treated only withsurface treatment. For these juices,drops may not be used. The NACMCFsuggested, and FDA agrees, that forcitrus juices, only tree-picked fruitshould be used, and fruit should becleaned and culled to be USDA choiceor higher quality. Although pathogeninfiltration is unlikely in sound, intactcitrus fruit, drops and damaged fruit are

likely to be more susceptible topathogen infiltration and, therefore,should not be used for juice that relieson surface treatment.

Furthermore, in some cases, damageincurred when fruit drops to the groundmay foster nonmicrobial contaminationsuch as the mycotoxin patulin, whichmay occur in damaged apples. Patulin,if present in the apples, will not bedecreased by the 5-log performancestandard. In these cases, the processormust have controls in place to ensurethat the final juice does not containunsafe levels of the mycotoxin.

(Comment 134) Several commentsurged FDA to define sound fruit. A fewcomments noted that culling is asubjective process and therefore maynot be consistently applied. Onecomment suggested that the agencyestablish mandatory common minimumstandards and technologies (e.g., blacklighting) to ensure consistency inculling operations. Another commentsuggested that FDA specify that fruit beculled of unsound fruit before dirty fruitis placed into a flume where it mightcontaminate sound fruit.

In the case of citrus juice where asurface treatment is used to achieve, atleast in part, the 5-log reduction, theagency has specified that the fruit shallbe ‘‘culled’’ and ‘‘cleaned.’’ As noted,these terms are defined in § 120.3. Fruitand vegetable grading criteria (e.g., forUSDA choice level or higher, as will berequired for surface treated citrus fruit)have been established by USDA.Although there may be some degree ofsubjectivity in culling citrus fruit,visibly damaged fruit is apparent and isunlikely to meet the requirements forUSDA choice level or higher.Application of CGMP’s, along with the5-log performance standard beginning ata point after cleaning and culling ofcitrus fruit, should overcome anypotential risks that may result fromsubjective processes such as culling.

As stated in response to comment132, FDA is not setting a standard forfruit where the juice is treated afterextraction to achieve a 5-log reduction,although processors may considerincluding standards for incoming fruitas appropriate to their operations inestablishing a HACCP plan. Additionalguidance will be provided in theagency’s juice HACCP hazards andcontrols guidance.

(Comment 135) Several commentsrequested that FDA develop a guide forindustry that states the log reductionachieved for each potential processingstep. A few comments requested thatpasteurization guidelines for juice bepublished in a guide, and one commentasked whether or not heat treatment at



161 °F for 15 seconds results in theappropriate 5-log reduction in juice.Another comment questioned how tocalculate a 5-log reduction for bananajuice.

FDA plans to publish a juice HACCPhazards and controls guidance to assistthe juice industry in implementingthese regulations. FDA intends that theguidance will contain pasteurizationguidelines and information aboutachieving the performance standard inother ways. The agency is unable tocomment on whether a heat treatment of161 °F for 15 seconds results in a 5-logpathogen reduction without informationabout the characteristics of the juice aswell as the thermal resistancecharacteristics of the pathogen ofconcern. Appropriate 5-log pathogenreduction treatments for specific juices(such as banana juice) will vary,depending on the characteristics of thejuice (e.g., acidity, viscosity, percentageof pulp) and processing conditions.Processors may find it necessary toconsult additional resources todetermine and implement the mostappropriate process to achieve the 5-logpathogen reduction, such as informationfrom State public health or agricultureagencies, universities, extensionservices, and private consultants. Theagency emphasizes that it is theprocessor’s responsibility to validate thechosen pathogen reduction process toassure its effectiveness in consistentlyachieving a 5-log or greater reduction.

(Comment 136) Many commentsexpressed confusion about the use ofcumulative steps to reach the 5-logpathogen reduction requirement. A fewcomments also requested that FDAclarify exactly what would be requiredif two different processors perform stepsthat in the final product add up to a5-log reduction. A number of commentsstated that separating cumulativepathogen reduction steps by time and orby location is not acceptable. Thesecomments argued that such separationprovided opportunities forrecontamination of product andregrowth of any existing pathogens thathad not yet been eliminated in theproduct, that any multiple stepintervention should take place in asingle location, and urged FDA toensure time between treatments is keptto a minimum once an interventionsequence is begun. Several commentson transporting juice between facilitiessuggested that FDA require that bulktransport juice (e.g., juice shipped intanker trucks) be pasteurized uponarrival at the final facility because of thepotential for contamination duringtransport.

FDA agrees with the commentsexpressing concern about the potentialfor recontamination or regrowth ofsurviving pathogens if individualtreatments designed to achieve a 5-logreduction are separated by time orspace. At the December 8 to 9, 1999,meeting of the NACMCF, FDA asked theCommittee to consider certain questionsabout the application of the 5-logreduction standard, focusing on citrusjuices. Questions included the impact ofseparation in time and space betweencumulative steps in the 5-log reductionprocess. The Committee membersagreed that separating steps in the 5-logreduction by time, and especially bylocation, is likely to increase the risk offailure of the pathogen reductionprocess (Ref. 12). Thus, the NACMCFrecommended that all the steps neededto achieve the required 5-log reductionshould occur under one firm’s controland within a single production facility.These restrictions are designed toreduce the risk of recontamination ofjuice already processed to achieve all orpart of the 5-log reduction. Both timeand the act of transportation, betweenprocessors, present an opportunity forrecontamination. Even if a processormoves product from one building toanother within the same facility, thismovement must be accomplished underCGMP’s and the processor must insurethat recontamination does not occur. Asnoted, there have been several recentoutbreaks of microbially contaminatedfresh juice; investigation of theseoutbreaks establish that the concernabout recontamination is not justtheoretical because the evidencesuggests that transportation may haveplayed a role in these outbreaks. InApril 2000, FDA was notified by CDC ofa foodborne disease outbreak involvingover 140 reported cases from 10 States.CDC determined that the illness wascaused by Salmonella Enteritidis inunpasteruized orange juice, acomponent of which had been importedin bulk. Previously, in July 1999, anoutbreak of Salmonella SerotypeMuenchen occurred in 15 States and 2Canadian provinces with over 300 casesreported. Again, the product was freshorange juice, a portion of which wasimported. In this second outbreak,several serotypes of Salmonella wereisolated from tanker truckloads of juicetested at the United States/Mexicanborder (Ref. 67).

FDA agrees with the NACMCFrecommendations that all the stepsneeded to achieve the required 5-logreduction should occur under one firm’scontrol and within a single productionfacility. Although the NACMCF

recommendation focused on citrusjuice, based on the comments, FDAbelieves that this recommendationshould be extended to all juices.Because of the potential forcontamination at a facility over whichthe final processor/packager has little orno control and because of the potentialfor contamination during bulk transport,FDA has concluded that there shouldnot be any carryover from one facility toanother of any portion of pathogenreduction that contributes to a total 5-log pathogen reduction. If a treated juiceis transported to another facility forfinal packaging or blending andpackaging operations, the entire 5-logreduction must be repeated. To clarifythis point, the agency is addingparagraph (c) to § 120.24 to state thatprocessors must complete the 5-logperformance standard and final productpackaging within a single processingfacility under CGMP’s.

FDA also notes that, for citrus juiceproducers relying on surface treatmentsfor the 5-log reduction, the singlefacility criterion also applies to therequirement that processors start withclean, choice or higher grade fruit.Although some juice processors mayreceive fruit that has been cleaned andgraded at another facility, fruit mayrequire additional cleaning and cullingto remove any fruit damaged in storageor transit. It is the responsibility of thefinal juice processor (i.e., the processorat the location where the 5-log treatmentwill be applied) to ensure that fruit isclean and of appropriate grade beforebeginning the 5-log reduction.

Even within a single productionfacility, time between cumulative stepsmay provide an opportunity for growthor recontamination. Therefore,processors should include in theirHACCP plans controls to protect againstregrowth of pathogens between steps(e.g., limiting hold time and/ortemperature) and to preventrecontamination of the juice during orafter processing (e.g., aseptic handlingbetween steps or between treatment andpackaging).

FDA also agrees with the concernexpressed by comments on the potentialfor juice to be contaminated during bulktransport. This is an area of particularconcern to the agency because, asmentioned above, bulk transportappears to be a common factor inseveral recent outbreaks. However, theagency has no information nor was anyinformation submitted by commentsthat the 5-log reduction standardapplied to juice in general would not besufficient to ensure the safety of juicethat is shipped in bulk, provided thatthe transported juice receive the entire



5-log reduction at the facility where itwill be packaged. Therefore, FDA is notrequiring at this time that juice shippedin bulk between facilities be subject toadditional treatment.

(Comment 137) One commentexpressed concern that a cumulativeprocess will be more easilyoverwhelmed by especially dirty fruitthan would a single kill-step process.The comment contended that the risk ofcontamination in a multi-step process isincreased over the risk in a single kill-step process because of the potentialthat contamination can be introducedbetween steps. One comment expressedconcern that validation studies on acumulative 5-log reduction cannotaccount for all variables and, thus,meeting the performance standardcannot be guaranteed.

HACCP principles and this final rulerequire that a processor validate theHACCP plan for its particular processunder commercial operating conditions.This validation requirement exists forplans utilizing both single-step andcumulative pathogen reduction controls.FDA recognizes that within a processingsystem time delays may occur betweenstages of the treatment; the processormust take any delays into consideration,establish appropriate controls, andvalidate the HACCP plan for thatsystem. The 5-log reductionperformance standard was establishedto ensure the safety of juice regardlessof the pathogen reduction systemchosen or the microbial load of theincoming fruit. Furthermore, asdiscussed in response to comment 132,citrus juice processors using surfacedisinfection to achieve all or part of the5-log reduction must start with cleanedand culled fruit as defined in § 120.3 (a)and (f).

(Comment 138) Several commentsmaintained that juice should bepackaged immediately before or afterthe intervention treatment. Onecomment stated that a processor couldhold and cool a heat treated productbefore packaging if sufficient controlswere in place to precluderecontamination of the product.

As noted earlier, time betweencumulative steps and betweenapplication of the 5-log reduction andpackaging increases the risk of failure(see response to comment 136).Therefore, to reduce the risk ofrecontamination, juice should bepackaged immediately before or afterapplication of the 5-log pathogenreduction treatment. The potential forrecontamination between application ofthe 5-log reduction treatment andpackaging (such as might occur whenproduct is held and cooled) should be

considered in the development of theHACCP plan and appropriate controlsestablished that are designed to preventrecontamination. Processors notpackaging juice immediately aftertreatment should have sufficientcontrols in place (e.g., asepticequipment) to ensure the safetyachieved by the 5-log reduction can beconsistently maintained.

(Comment 139) One comment askedif the regulation allowed for theapplication of 5-log reduction to a juiceingredient at any time (e.g., before orafter blending). The comment arguedthat the juice ingredient used tomanufacture dairy beverages usuallyreceives a 5-log treatment by thesupplier and that the finished beverageis often pasteurized at the dairy.

Juice that is intended for use infurther manufacturing is generallyshipped in bulk. As discussed in theresponse to comment 136, the NACMCFrecommended and FDA agrees that ifbulk transport juice will be repackagedat another facility, the 5-log reductionprocess must be performed on the juiceat the facility where it is packed intofinal packages. If treated juice ispackaged into a bulk-type sterilepackage, such as a single use sanitarytote, then reprocessing is not necessaryunless it is repackaged. If juice shippedin sterile totes is to be repackaged at adifferent facility, the juice product soldto consumers must be retreated to attainthe 5-log reduction at the facility wherefinal packaging is performed. Asdiscussed earlier, separation in time andlocation increases the risk of failure ofthe HACCP system, including the 5-logreduction. Therefore, FDA is notproviding for carryover of any part ofthe 5-log reduction when juice, not inits final packaged form, is transportedbetween two facilities.

Juice destined for use as an ingredientin another juice beverage must alsoundergo a 5-log reduction process. Theprocessor may choose either to treat thejuice ingredients before blending or totreat the final product, so long as theentire 5-log reduction is completed in asingle production facility under thecontrol of the processor and theprocessor minimizes time betweentreatment and packaging.

(Comment 140) Several commentsnoted that shelf-stable juices areprocessed well in excess of the 5-logreduction necessary for pathogencontrol. The comments requested thatFDA exempt shelf-stable juice producersfrom a CCP for pathogen reductionbecause the shelf-stability of the productis proof that their process greatlyexceeds safety performance criteria.Comments also requested that the same

consideration be given to concentratedjuices.

The agency agrees with the commentsand is providing an exemption from therequirements of § 120.24 for shelf-stableand concentrated juices, under specificconditions. Shelf-stable juice productsare generally processed at hightemperatures in a single step to destroyspoilage microorganisms and enzymes(Ref. 68). These temperatures far exceedwhat is needed to attain the 5-logreduction in the pertinent pathogen.Therefore, FDA concludes that it isreasonable to exempt a processor ofshelf-stable juices from the requirementsof § 120.24, if the firm uses a singlethermal processing step to attain shelf-stability.

FDA also recognizes that theproduction of thermally concentratedjuice utilizes thermal treatments similarto those used for the production ofshelf-stable juices (Ref. 68). A thermalconcentration process generally consistsof an initial thermal treatment, similarto that used for shelf-stable juices,followed by several thermal evaporationsteps. For this reason, the agency hasconcluded that when a thermalprocessing step is used before a thermalevaporation process, the processorshould be exempt from the 5-logreduction requirement.

Accordingly, FDA is adding§ 120.24(a)(2) exempting juiceprocessors using a single thermalprocessing step sufficient to achieveshelf-stability of the juice or a thermalconcentration process that includesthermal treatment of all ingredientsfrom the requirements of § 120.24 (the5-log reduction requirement). Whencompleting the written hazard analysisas required by § 120.7, processors ofshelf-stable and concentrated productsusing a thermal treatment need notidentify pathogens as a hazard that isreasonably likely to occur. Todemonstrate that its process is sufficientfor the exemption, a processor mustinclude a copy of the thermal processused to achieve shelf-stability orconcentration in its written hazardanalysis as required by § 120.7.

Shelf-stable or concentrated juiceprocessors are not exempt from therequirement to conduct a written hazardanalysis because of the possibility thatchemical or physical hazards may bereasonably likely to occur. However, if,based on its hazard analysis a processorexempt from § 120.24 determines thatthere are no chemical or physicalhazards that are reasonably likely tooccur in its juice product, then thatprocessor is not required to have aHACCP plan. Juice processors that donot have a HACCP plan need not



comply with the following provisions ofpart 120:• § 120.8, HACCP plan• § 120.10, Corrective actions• § 120.11(a) (except paragraph

(a)(1)(i)), Verification• § 120.11(b), Validation of the HACCP

plan• § 120.12(a)(3) and (a)(4), Required

records• § 120.24(a) (except paragraph (a)(2)),

Process controls• § 120.25, Process verification for

certain processorsFDA anticipates that, in the future,

processors making shelf-stable orconcentrated juice may use alternativenonthermal processing technologies.While the control mechanism of thesenonthermal technologies may eliminatespoilage microorganisms, the effect onpathogens is uncertain. Therefore, theexemption under § 120.24(a)(2) does notextend to nonthermal processes.

5. Validation of the PerformanceStandard

(Comment 141) One comment statedthat the cost of validating a 5-logreduction procedure would beprohibitive to small producers becausethe validation studies would have totake place in a pilot plant. Anothercomment stated that processors shouldbe able to validate procedures andcritical control limits based on literaturereviews, in-plant experience,recommendations from consultants, androutine testing.

The agency disagrees with thecomment that argued that validationwould be too expensive for smallprocessors because it would have to takeplace in a pilot plant. FDA notes thatvalidation studies need not occur in apilot plant. There are several optionsavailable to a processor in validating its5-log reduction procedure and inestablishing critical limits. Although itis preferable to establish limits for CCP’sand validate individual processes in apilot plant or in the processing facilitywhere they will be carried out, FDArecognizes that this may not be feasiblefor small processors. As suggested bythe second comment, many alternativesare available. For example, smallprocessors that use identical proceduresfor producing juice could validate theseprocesses cooperatively. It is alsoacceptable to use referenced proceduresfor achieving a particular log reductionprovided a processor can demonstratethat the referenced procedure is beingfollowed exactly (or more stringently),as outlined in the literature, and iseffective in the processor’s operation.Small producers may also elect to useproven technologies (e.g., thermal

treatments) that have been extensivelyvalidated, and as such can be readilyadopted with minimal need to conductin depth microbiological validationtesting.

FDA was unsure what the secondcomment meant when referring to‘‘routine testing’’ as a way to validateHACCP. It may be that the comment wasreferring to ‘‘verification’’ (e.g., routinetesting and monitoring) to ensure thatthe HACCP plan is functioningcorrectly, rather than ‘‘validation’’.Verification and validation are furtherdiscussed in the following section.

6. Process Verification(Comment 142) Several comments

expressed concern about theeffectiveness of cumulative steps inmeeting the 5-log reduction. Onecomment pointed out that the efficacy ofa cumulative step process for citrusassumes perfect grading and that theinterior of citrus is sterile. The commentstated that perfect grading is notpossible because pathogens that mayhave entered the fruit through amicroperforation may not be detectedand the fruit could have a contaminatedinterior. The comment also maintainedthat no steps in the cumulative processdescribed in the proposed rule weredesigned to prevent reproduction ofpathogens in the juice during storage. Afew comments concerned about theeffectiveness of cumulative treatmentsargued that FDA should require end-product testing to verify HACCP for allnon-pasteurized juice. One commentadvocated continuous testing forunpasteurized juice and periodic testingfor pasteurized juice. Conversely, onecomment maintained that, in mostcases, microbial testing is not necessarynor is it the best method for verifyingHACCP. However, this commentsuggested that microbial testing berequired for citrus juice using surfacetreatments to achieve 5-log since,according to the comment, there are fewother steps that can be used to verifycumulative processes that includesurface treatment.

FDA’s response to these commentsrequires an understanding of thedifferences between two HACCPconcepts: validation and verification.Verification includes all activities,except monitoring, that establish thesoundness of the HACCP plan and thatthe system is operating according to theplan. Many verification activities, suchas process verification, are an on-going(e.g., daily or weekly) part of operatingunder a HACCP plan. Validation is asubset of verification activities thatoccurs when a HACCP plan is first setup and whenever significant changes

are made that may have an impact onthe effectiveness of the system.Validation focuses on collecting andevaluating scientific and technicalinformation to determine whether theHACCP plan, when properlyimplemented, will effectively control allhazards that are reasonably likely tooccur. In contrast, verification assesseswhether the HACCP plan, onceestablished, is working properly.

FDA disagrees that microbiologicaltesting of the final juice should berequired of all juice manufacturers. Ifjuice is treated to achieve a 5-logreduction in a target pathogen after thejuice is expressed, the extent of thereduction (>100,000-fold) incombination with the low levels ofpathogens that have been detected inuntreated juice would likely result in apost-treatment level of microorganismsthat is too low to be detected usingreasonable sampling and analyticalmethods. Moreover, microorganisms arenot likely to be uniformly distributedthroughout the juice and, accordingly,may not be present in the sample testedeven though they are in the juice. Thiscan result in false negative test results.Determination that the product has beenadequately treated is more effectivelyverified by review of the monitoringrecords for the appropriate CCP. Thus,as a general rule, FDA is not requiringend product testing as part ofverification for processes where thejuice itself has been directly treated. Theexception to this general rule is thatprocessors of citrus juice that usesurface treatments to achieve the 5-logreduction performance standard will berequired to conduct end product testingto verify that their HACCP system,including the cumulative step 5-logreduction, is operating as it is designedto operate. This verification testing isdiscussed in more detail below. Ofcourse, even where not required,processors may elect to use end producttesting as part of the verification of theHACCP plan.

Conversely, except for techniques likepasteurization, where industry has along history and experience of usingtime-temperature parameters as anindicator of microbial destruction, aprocessor will likely need to conductstudies using samples inoculated withpathogens (or surrogates) to confirm thattheir HACCP process does result in a5-log reduction in the pertinentpathogen.

In light of comments expressingconcern about the efficacy of cumulativesteps, including surface treatment ofcleaned and culled citrus fruit, FDA hasevaluated the need for additional formsof process verification for some



products. As noted, verification isdesigned to demonstrate that theHACCP plan is achieving the level ofprocess control intended and thusproducing safe food on a continuingbasis. Verification is broader thanongoing process monitoring alone. Thepurpose of monitoring is to measure anddocument that those identified stepsthat must operate within specifiedlimits on a continuing basis in order tocontrol a foodborne hazard (i.e., CCP’s)are in fact operating withinspecifications. Ideally, monitoringinvolves continuous, ‘‘real-time’’measurements so that processdeviations can be detected andcorrected immediately.

Conversely, verification entails boththe periodic review of monitoring dataand the acquisition of additional data toassess whether the HACCP plan isfunctioning as intended. The additionaldata are not necessarily data relating toa CCP, but could be data relating toanother step in a process that reflectsthe effectiveness of a prior CCP(s) (e.g.,sampling of citrus fruit surfaces forlevels of acid resistant mesophilicaerobic microorganisms after treatmentof the fruit with an acidic antimicrobialwash). Furthermore, since verificationdata are only acquired on a periodicbasis, types of analyses that require toomuch time to be effective means formonitoring CCP’s can nevertheless behighly effective tools for verifying aHACCP plan. Verification activities mayinclude review of CCP-monitoringrecords; collection of either in-line orfinished product samples formicrobiological, chemical, or physicalanalysis; and direct observations ofmonitoring activities and correctiveactions. The frequency of verificationactivities will vary depending on factorssuch as the type of process, volume ofproduct, the results of prior monitoringand verification activities, and pastfrequency of process deviations.

As discussed in detail previously, atits December 1999 meeting, theNACMCF considered at length theeffectiveness of surface treatment toeliminate microbiological concernsrelated to citrus fruits. There has beena continuing question of whether theintegrity of the outer surface of citrusfruit is sufficiently impervious such thatpathogenic microorganisms cannot enterthe fruit. If the surface were sufficientlyimpervious, surface treatments mighteffectively reduce the risk frommicrobiological hazards. The NACMCF(1999) concluded that the potential forthe uptake and growth of bacterialpathogens such as Salmonella Hartfordand E. coli O157:H7 by intact citrus fruitis unlikely, given current industry

practices, and that surface treatment ofintact, healthy citrus fruit shouldadequately reduce microbiological risks.However, the NACMCF also concludedthat under certain limited conditions,internalization of pathogenic bacteria ispossible. Further, the NACMCF notedthat surface treatments of fruits wouldhave little effect on internalizedpathogenic microorganisms (Ref. 12). Inaddition, although the NACMCFconcluded internalization of pathogensin sound citrus is unlikely undercurrent industry practices, FDA researchconfirmed that if a temperaturedifferential exists between the fruit andwash water, washing may causeinternalization of pathogens in citrusand other produce through indiscerniblepunctures of the skin.

The NACMCF observed that whilemicrobiological testing is seldomeffective as a means of monitoring aCCP, such testing can play a role inverifying HACCP programs (Ref. 17).Similarly, the International Commissionon Microbiological Specifications forFoods (Ref. 69) has recognizedmicrobiological testing of product asone type of HACCP verification.

In relation to HACCP and citrus juicemanufacture, the NACMCF (Ref. 12)recommended that periodicmicrobiological testing of juice be acomponent of the HACCP verificationactivities undertaken by those citrusjuice manufacturers who rely on surfacetreatment of fruit to achieve all or partof the microbiological performancestandard (5-log reduction).

Because of continuing questions aboutthe possibility of pathogeninternalization and because of the lackof alternative verification steps availablefor processors using cumulative steps,including surface treatments, to achievethe 5-log reduction, FDA concludes that,for citrus juices that rely solely or inpart on surface treatments, periodicmicrobial testing to verify theeffectiveness of cumulative processes isintegral to the process controlverification. Therefore, in § 120.25, FDAis requiring microbial testing for suchjuice products. This testing is inaddition to verification and validationrequirements set forth in § 120.11.

(Comment 143) As noted above,several comments argued that FDAshould require microbial testing forsome or all juices. Some commentsfavored microbial testing of finishedproduct but did not specify samplingplans or methods. A few commentssuggested that FDA could permitcompanies to test for indicatororganisms because E. coli O157:H7 ishard to detect. One comment argued

that such a requirement wouldeliminate the need for a HACCP system.

FDA disagrees with the comment thatmaintained that end product testingwould eliminate the need for HACCP forjuice. As discussed in response tocomment 142, microbial testing islimited in its ability to detect processdeviations in a timely manner,especially for products with a shortshelf-life, such as fresh juice.

FDA agrees with the comment thatsuggested that indicator organismscould be used for process verification.While microbiological testing forspecific pathogens might be a directmeans of verifying that a surfacetreatment is effective and that pathogenshave not been internalized in the fruit,analyses for individual pathogens canbe highly complex. Testing forpathogens also has limitations,including the potential for pathogens tobe present at low levels compared toother microorganisms and the detectionlimit of the test. There is also thequestion of which pathogens that maybe present on the surface of the fruitshould be the focus of any testing. Forexample, testing for Salmonella, E. coliO157:H7, and Cryptosporidium parvummight be appropriate since all threehave been implicated in diseaseoutbreaks related to juices. Anotherlimitation of testing for pathogens is thattesting for one pathogen (e.g.Salmonella) will not detect another(e.g., E. coli O157:H7), even if thesecond pathogen is present. Analternative would be to select amicroorganism whose presence isindicative of a loss of process control.Since all three of the pathogens aboveare fecal in origin, the ideal indicatormicroorganism would be one that isindicative of fecal contamination.

FDA has considered several differentpossible indicator microorganisms andhas concluded that biotype I Escherichiacoli (i.e., generic E. coli) is the mostsuitable indicator microorganism forverifying the effectiveness of surfacetreatments in attaining the 5-logreduction standard. This microorganismis generally regarded by the scientificcommunity as the best indicatormicroorganism for processes intended tocontrol fecal contamination (Refs. 15and 70). When present, generic E. coligenerally occurs at levels severalmagnitudes greater than the levels ofenteric pathogens that are associatedwith fecal contamination. Consequently,testing for generic E. coli is more likelyto detect product where the 5-logreduction standard has not beenachieved. Thus, FDA concludes that anycitrus juice manufacturer that reliessolely or in part on surface treatment of



the fruit to achieve the 5-log reductionperformance standard shall, for eachdifferent type of juice productproduced, conduct analyses of the finalproduct for biotype I Escherichia coli.

The next issue is how the analysisshould be performed. Historically, thejuice industry has used the standard3-tube MPN (most probable number)method in FDA’s BacteriologicalAnalytical Manual (BAM) for analysis ofcoliform and E. coli in juices. However,this method has several limitations.First, as noted in a paper entitled‘‘Derivation of Sampling Plan to Meetthe Testing Requirement in the JuiceHACCP Final Rule for Citrus Juices ThatRely Solely Or in Part on SurfaceTreatments to Achieve the 5-LogReduction Standard’’ (‘‘SurfaceTreatment Sampling Plan’’) (Ref. 71),the BAM method can only analyze asmall sample size of 3.33 mL with adetection limit of 0.3 E. coli/mL. Inaddition, the high acidity of somejuices, including most citrus juices, caninterfere with the detection efficiency ofthe test. Using an analytical method thatcan test a larger sample size (i.e., 20 mL)and by including an enrichment step toreduce interference by acidity shouldimprove an analysis for generic E. coliand thus assist a citrus juice processorusing surface treatments to verifywhether the process is achieving the 5-log reduction. Consequently, FDA hasdeveloped the method, ‘‘Analysis forEscherichia coli in Juices—Modificationof AOAC Official Method 992.30,’’ todetect the presence or absence of E. coliin a 20 mL sample of juice (consistingof two 10 mL subsamples) (Ref. 72). Inthe future, FDA intends to place thismethod in the BAM. After publicationof this final rule, the method will beavailable on FDA’s Internet site atwww.cfsan.fda.gov.

In order to facilitate uniform andeffective application of thisrequirement, FDA has added to§ 120.25, specific requirements forsample collection and testing. Underthis provision, one 20 mL sample,consisting of two 10 mL subsamples, offinished juice shall be analyzed for thepresence of generic E. coli from each1,000 gallons of juice produced per day.If less than 1,000 gallons of juice areproduced per day, samples must betaken for each 1,000 gallons produced,or once every 5 working days that thefacility is producing that juice,whichever comes first. If either 10 mLsubsample is positive for E. coli, thenthe 20 mL sample is recorded as beingpositive for generic E. coli.

In addition to the general correctiveaction requirements in § 120.10, FDA isalso adding requirements in § 120.25 to

spell out the specific steps that shouldbe taken if a processor subject to therequirements of § 120.25 finds one ormore juice samples positive for E. coli.Generic E. coli is relatively ubiquitous.Thus, the occasional sample that ispositive for E. coli does not necessarilyindicate that microorganisms of fecalorigin are not restricted to the surface ofthe fruit or that surface treatments areinsufficient to assure product safety.Nevertheless, an occasional positivesample should prompt a review of themonitoring records relating to the 5-logreduction standard to determinewhether pathogen reduction treatmentsand post process controls designed toprevent re-contamination are beingproperly delivered. Because generic E.coli is an indicator of fecalcontamination, processors findinggeneric E. coli in a single sample mayconsider testing another sample of thesame juice for specific pathogens ofconcern, such as Salmonella and E. coliO157:H7, to determine whether, in fact,pathogens are present in the juice. FDAis not requiring pathogen testing for theoccasional, single positive for E. coli.However, if the review of monitoringrecords or the additional testing showsthat the 5-log reduction has not beenachieved, such as a sample is found tobe positive for the presence of apathogen or a deviation in the processor its delivery is found, the processorshall take corrective action as set forthin § 120.10 of this final rule. Correctiveaction requirements for a single positivegeneric E. coli are set forth in 120.25(d).

More than an occasional 20 mLsample positive for generic E. coli is anindication that the HACCP process isnot sufficient to assure product safety.Under § 120.25, processors relying inwhole or in part on surface treatmentsof the fruit shall have in place asampling and testing plan sufficient todistinguish between the occasionalpositive sample and more frequentpositives that are indicative of a failureto deliver the 5-log reduction. One wayto distinguish between a chance eventand an event that results from otherfactors (such as a failure to deliver the5-log reduction) is to examine a definedseries of tests and assess whether theunusual happens too frequently to bedue to chance alone. FDA has evaluatedthe available data and information, andbased on that analysis, has determinedthat two positives in any series of sevencontiguous tests is an appropriatecriterion in a sampling plan designed tosignal a citrus juice processor relying onsurface treatments that its 5-logreduction standard has not beenachieved. This standard would alert

processors relatively quickly that theirsystem is not delivering the 5-logreduction and, at the same time, wouldhave a relatively small incidence of‘‘false alarms’’ for processors who areachieving a 5-log reduction. Thestatistical basis for this criterion isdescribed in the paper entitled‘‘Derivation of Sampling Plan to Meetthe Testing Requirement in the JuiceHACCP Final Rule for Citrus Juices ThatRely Solely Or in Part on SurfaceTreatments to Achieve the 5-LogReduction Standard’’ (SurfaceTreatment Sampling Plan) (Ref. 71).

FDA acknowledges that there werecertain limitations in the data it hadavailable to estimate E. coli levels thatwould be expected in juice not treatedto reduce pathogenic microorganisms.For example, available data on E. colilevels in citrus juice were limited toorange juice. However, FDA believesthat the sampling plan set out in theSurface Treatment Sampling Plan (Ref.71) can appropriately be applied to alltypes of citrus juice. Orange juicerepresents a significant portion of thecitrus juice market. For those citrusjuices that have a lower occurrence of E.coli compared to orange juice, using thesame sampling plan will provide anequivalent or greater level of food safetyassurance for consumers withoutincreasing any burden, such as the riskof false alarms, for processors.Moreover, a single standard samplingplan will simplify implementation andevaluation of HACCP for citrus juiceprocessors using surface treatments.Other aspects of the data, including itslimitations, are discussed in the SurfaceTreatment Sampling Plan (Ref. 71). FDAbelieves that the assumptions made,based on its review of available data,were sufficiently sound and reasonableto support this sampling plan.Therefore, FDA is specifying in§ 120.25(e) that finding two samplespositive for E. coli out of a series ofseven sequential tests indicates that the5-log reduction was not achieved. Asadditional data become available, theagency will consider those data andmake adjustments in the HACCPregulation or in the Juice HACCPhazards and controls guide asappropriate.

Under § 120.25(e), if a processor findstwo positives out of seven tests, thecontrol measures to achieve the 5-logreduction would no longer beconsidered adequate. This wouldrequire immediate action to ensure thatno product enters commerce that wasproduced where the 5-log reduction wasnot achieved, because inadequatelyprocessed juice creates the potential forthe transmission of foodbourne



illnesses. In addition, the processorswould need to determine the source ofthe failure and to take steps to correctthe failure. Corrective actions mustinclude a review of the monitoringrecords for control measures to attainthe 5-log reduction standard, and theprocessor must correct those conditionsand practices that are not met. If thereview of monitoring records or theadditional testing shows that the 5-logreduction has not been achieved, suchas a deviation in the process or itsdelivery, the processor shall takecorrective action as set forth in § 120.10of this final rule. The processor shouldalso review the aspects of the HACCPplan relating to the 5-log reductionstandard to determine whether theconditions and practices specified in theplan relating to the 5-log reductionstandard are being met. If thoseconditions and practices are being met,and no other source of the problem canbe found (e.g., post processcontamination), the processor shouldconclude that the treatment, althoughdelivered as intended, was not able toachieve the intended 5-log pathogenreduction. In such case, the processorshall revalidate its HACCP plan inrelation to the 5-log reduction standard.

While the control measures relating tothe 5-log reduction standard are beingevaluated, and until all correctiveactions have been completed, including,if necessary, revalidation of thoseaspects of the HACCP plan relating tothe 5-log reduction standard, theprocessor must use an alternativeprocess or processes to achieve the 5-logreduction after the juice has beenexpressed. Processors should considerwhy the monitoring and verificationresults are not in accord, such asthrough an inadequate process or afailure in process delivery, and whetheran alternate approach to achieving the5-log reduction is needed. Once thesesteps have been taken, processors mayagain use the validated approach thatrelies solely or in part on surfacetreatments rather than the alternativeprocess.

FDA has concluded that two positiveE. coli samples in a series of seven testsindicate that the control measures toattain the 5-log reduction standard areinadequate and immediate correctiveactions are necessary. Two positives ina window larger than seven tests may bedue to chance rather than a failure todeliver the 5-log reduction. However,processors may wish to review testresults over a larger window as apossible early warning that the processmay be approaching failure. FDAintends to provide additionalinformation in its Juice HACCP hazards

and controls guide to assist processorsin ensuring their review is sufficientlyextensive to determine that no trendstowards loss of control are occurring.

The agency concludes that new§ 120.25 is a highly effective tool forverifying the 5-log reduction standardfor processors using surface treatments.In addition, FDA is modifying§ 120.11(a)(1) to include new paragraph(vi) to clarify that the activities in§ 120.25 are part of the processor’sverification activities.

7. Other Issues(Comment 144) One comment

requested that FDA clarify what ismeant by moderate abuse conditions.The comment stated that E. coli may beless tolerant under these conditions, somoderate abuse could be a kill step forE. coli.

FDA discussed what it considered tobe moderate abuse in the proposal (63FR 20450 at 20478) (Ref. 2). FDAacknowledges that in somecircumstances moderate abuse such asslightly elevated temperature in anacidic juice may actually decrease thenumbers of certain microorganisms. If aprocessor intends to use a specificperiod of elevated holding temperatureas a treatment, then the processor mustvalidate the treatment as required forany CCP.

(Comment 145) A few commentsasked that FDA eliminate therequirement that the 5-log reduction bemaintained throughout shelf-life of theproduct. The comments maintained thatthere is no risk of recontamination oncethe juice is bottled.

FDA agrees that there is little risk ofrecontamination after a juice is bottledif the container is not damaged and thejuice is handled under CGMP’s.However, because of the importance ofattaining the 5-log reduction for juice tobe safe, it is reasonable that juice retainthis characteristic throughout the periodthat it is available for consumption byconsumers. Therefore, FDA is notamending § 120.24.

(Comment 146) One commentsuggested that the performance standardshould be phased in as data on meetingthe performance standard becomesavailable. Another comment suggestedthat initially, a 3-log reduction could berequired, then the following year a 4-logreduction would be required and finallya 5-log reduction.

The agency does not agree. FDA isproviding ample opportunity toaccommodate processors that may havedifficulty implementing the 5-logreduction performance standard. First,the agency has required, since theeffective date of the juice labeling final

rule, that juice be treated to controlpathogens (i.e., meet a 5-log reductionperformance standard) or bear a warninglabel statement. Since that same time,FDA also has been working with thejuice industry, through workshops andprograms, on the development oftechniques that meet the performancestandard. Finally, depending on theirsize, processors will have 1 to 3 yearsto implement this rule because theagency is providing additional time forsmall and very small businesses toimplement their HACCP systems.Therefore, FDA concludes that it hasalready provided the means andreasonable time for processors toidentify and implement available meansto meet the 5-log reduction performancestandard.

M. HACCP Enforcement Issues(Comment 147) One comment

requested that FDA establish apreapproval system for HACCPincluding plant registration, filing ofHACCP plans, regular inspections,validation and verification of HACCPplans with microbial testing andtracebacks.

FDA believes that a preapprovalsystem for HACCP plans would undulyburden the agency’s resources withoutsubstantially increasing public healthbenefits. The effectiveness of a HACCPplan, including monitoring,recordkeeping, and verification, can bestbe evaluated under actual operatingconditions. Therefore, as part of itsenforcement plan for juice HACCP, FDAplans to do inspections of juiceprocessing facilities to ensurecompliance with the HACCP regulationsafter they become effective. Theseinspections will include collection andanalysis of product samples forpathogens and other contaminants.

The agency is putting juice processorson notice that FDA is committed toinspecting all high risk firms annually,even before the effective date of thisfinal rule, and intends to includesample collection and analysis as anintegral part of that process. In theagency’s view, processors of untreatedjuices, including firms producing citrusjuices using surface treatments, fall intothe category of high risk firms.

(Comment 148) One comment statedthat tracebacks are very important andthe need for information relating toorigin of the product was not covered inthe proposed rule.

FDA agrees that tracebacks areimportant and believes that the abilityto traceback from a foodborne illnessoutbreak to the source is critical tocontrolling the size and duration of theoutbreak. The source of an outbreak may



be contaminated raw produce orcontamination of product duringproduction and distribution. Processorsmust implement CGMP’s to address rawproduce suitability for processing and, ifthere are hazards that are reasonablylikely to occur in raw produce,implement HACCP controls for suchhazards. The recordkeepingrequirements of this rule mandate thatall records include the identity of theproduct and the production code whereappropriate. The purpose of theserequirements is to ensure that recordsmaintained under part 120 can bereadily linked to a product and to thetimeframe in which the product wasmanufactured. Linking a record to aspecific product will be especiallyimportant when a product must beisolated or recalled. The informationrequired in § 120.12 will help ensurethat, when tracebacks are necessary,they can be carried out efficiently.

(Comment 149) One commentsuggested that third party inspectionsshould be done to validate HACCP andthe results should be publicized.

FDA encourages such self-regulatedprograms within industry as third partyinspections. Validation of the HACCPplan may be done by any individual,including a third party, that has beentrained in accordance with § 120.13.The validity of the HACCP plan willultimately affect the overall compliancestatus of firms, as determined throughthe inspection process. This status ispublic information.

(Comment 150) One commentsuggested that FDA should model itsHACCP regulation after that of FSISwith more frequent and less lenientinspections and validation testing.

Differences in the way FDA and FSISimplement their HACCP programs aredue to differences in the products beingregulated. Also, FSIS’s authority andfunding provides for the presence ofinspectors in meat and poultry plants ona daily basis, whereas FDA’s authorityand resources do not require or allowfor such frequent inspections. FDA, tothe extent it is able, will work with juiceprocessors during inspections toproperly implement part 120.

(Comment 151) A few commentsquestioned whether FDA was planningto ask states to enforce the HACCPregulations in light of the agency’slimited resources. Another commentstated that the States should verifycompliance with any applicable safetyregulations.

FDA cannot mandate that a Stateensure that a firm is complying withFDA regulations. However, FDA has along history of working cooperativelywith the States to enforce food safety

regulations, and the agency hopes tocontinue these cooperative relationshipswith States in the context of juiceHACCP. FDA notes that some Statesadopt FDA requirements as their ownlaws and regulations; with those States,the final rule will effectively beenforced by the States.

(Comment 152) One commentrequested that first inspections ofHACCP systems be nonregulatory.

The agency recognizes the benefits ofa nonregulatory (i.e., educational) firstinspection of implementation of a newHACCP system. For the seafood HACCPprogram, FDA elected to make the firstinspection educational, rather thanregulatory, as long as there were nourgent public health problems. FDAchose that approach because, for mostprocessors, the first inspection providedthe first direct feedback from the agencyon the status of the firm’s HACCPsystem. FDA will consider whether thesame approach is warranted for some orall juice processors.

(Comment 153) One commentquestioned the type of training that FDAwould be providing its investigators toensure that they understand therelevance of microbial data and thatthey will not go on ‘‘witch hunts’’ tofind something wrong with the facility.

FDA’s food processor investigatorshave considerable experience withHACCP in that most are currentlyconducting seafood HACCP inspections.Investigators are trained to look forviolations of FDA regulations and toemploy discretion and good judgment(e.g., consider the significance of theviolation) in determining howinspectional findings are handled.Further, an investigator’s significantinspectional findings are reviewed bymultiple higher level FDA employees toconfirm the violation prior to theinitiation of any regulatory action by theagency.

N. Miscellaneous Issues(Comment 154) One comment

suggested that FDA develop a juiceHACCP pilot program.

FDA currently has a HACCP pilotprogram that includes juice processors.To date, two pasteurized juiceprocessors and one fresh juice processorhave completed the HACCP pilotprogram. FDA has used experiencegained from the participation of thesejuice processors in the HACCP pilotprogram in proposing and finalizing thisrule (Ref. 73).

(Comment 155) Several commentsstated that FDA should not imposeregulations on industry that will scareconsumers into buying only certainfoods (i.e., pasteurized juices).

It is not the aim of this rulemaking toscare consumers into buying onlycertain foods, such as pasteurizedjuices. However, juices have been thesource of a number of outbreaks ofillness and the death of one child, aswell as have contributed to the death ofan elderly man. Juices have also beenthe source of chemical and physicalcontaminants that have adverse publichealth effects, such as high lead levels,the presence of patulin, and thepresence of glass pieces. For thesereasons, the agency has determined thatmeasures are necessary to ensure thatjuice is safe and to prevent additionalillnesses and deaths, particularly amongat risk groups. The primary purpose ofthis rulemaking is to protect the public,not scare them. FDA believes that thesemeasures will promote publicconfidence in the safety of juiceproducts.

IV. Effective DateFDA proposed that any final rule

based on the proposal become effective1 year after its date of publication in theFederal Register. Further, FDAproposed that any final rule based onthe proposal would not be binding onsmall businesses as defined in§ 120.1(b)(1) until 2 years afterpublication in the Federal Register; andfor very small businesses as defined in§ 120.1(b)(2), the final rule would not bebinding until 3 years after publication inthe Federal Register.

(Comment 156) Many commentsexpressed concern that small businesseshave the longest time to comply withthe rules, even though outbreak dataindicate that these producers are mostlikely responsible for producingcontaminated juice.

The agency considered, in the HACCPproposal, the various issues surroundingthe need for processors to immediatelyimplement HACCP programs and theneed to consider options to minimizethe burden of the cost ofimplementation to small businesses (63FR 20450 at 20463) (Ref. 2). To addressthe most immediate concerns (i.e.,pathogens) with juice, FDA has sincefinalized the warning label statementregulation in § 101.17(g) and hasengaged in extensive education to alertconsumers to the problems ofconsuming untreated juice. All juiceshipped in interstate commerce or madefrom ingredients shipped in interstatecommerce, including that produced bysmall businesses, that has not beenprocessed to achieve a 5-log reductionin pathogens must be labeled with awarning for consumers (§ 101.17(g)).Thus, even if not produced under aHACCP system, the products of these



small businesses will have somesafeguards to protect public health. Inaddition to the label warningrequirement, FDA encouragesprocessors to implement a HACCPsystem as soon as possible to reducehazards in juice rather than use thewarning label statement. Consequently,the agency has decided to focus initialimplementation of HACCP onprocessors that produce the largestquantity of juice and thus have thepotential of affecting the largest numberof consumers should contaminatedproduct reach the marketplace.

(Comment 157) Several commentsrequested that the regulations becomeeffective for all processors 1 year afterthe rule is finalized and severalcomments requested that the regulationsbecome effective for all processors 2years after the rule is finalized.

The agency disagrees with thecomments. As noted, FDA consideredvarious options for the implementationof the effective date in the proposedrule. The final rule requires that thebulk of juice produced in the UnitedStates will be processed under a HACCPsystem within 1 year. The agencyrealizes that it may take longer for smalland very small businesses to fullyimplement HACCP systems and hasextended the effective date for one or 2years, respectively, to give themadequate time to comply.

V. Final Regulatory Impact Analysis

A. Introduction

FDA has examined the impact of thisfinal rule under Executive Order 12866.Executive Order 12866 directs Federalagencies to assess the benefits and costsof available regulatory alternatives and,when regulation is necessary, to selectregulatory approaches that maximizenet benefits (including potentialeconomic, environmental, public healthand safety effects; distributive impacts;and equity). Under the Executive Order,a regulatory action is ‘‘significant’’ if itmeets any one of a number of specifiedconditions, including having an annualeffect on the economy of $100 million;adversely affecting some sector of theeconomy in a material way; or adverselyaffecting competition or jobs. Aregulation is also considered asignificant regulatory action if it raisesnovel legal or policy issues. FDA findsthat this final rule is a significantregulatory action as defined byExecutive Order 12866.

The Small Business RegulatoryEnforcement Fairness Act of 1996(Public Law 104–121) defines a majorrule for the purpose of congressionalreview as having caused or being likely

to cause one or more of the following:an annual effect on the economy of $100million; a major increase in costs orprices; significant effects oncompetition, employment, productivity,or innovation; or significant effects onthe ability of United States-basedenterprises to compete with foreign-based enterprises in domestic or exportmarkets. In accordance with the SmallBusiness Regulatory EnforcementFairness Act, OMB has determined thatthis final rule is a major rule for thepurpose of congressional review.

In addition, FDA has determined thatthis rule is not a significant rule underthe Unfunded Mandates Reform Act of1995 (UMRA) requiring benefit-cost andother analyses. Under UMRA asignificant rule is defined as ‘‘a Federalmandate that may result in theexpenditure by State, local and tribalgovernments in the aggregate, or by theprivate sector, of $100,000,000 (adjustedannually for inflation) in any 1 year’’.

This Final Regulatory Impact Analysisreflects changes made in the regulationfrom the proposed rule to the final ruleand changes in estimates as a responseto comments. It also includes responsesto comments on the PRIA. Where therewere no changes in the estimatesprovided in the PRIA, the estimates aresummarized here. Interested persons aredirected to the text of the PRIA (Ref. 6)for a fuller explanation of the estimatesover which there was no controversy orchanges. The PRIA discussed a numberof regulatory alternatives. FDA receivedsome comments on these alternatives,however, none were specificallyeconomic in nature. Thus, FDA’sresponses to comments on thesealternatives are given in section III.1.There were no specific economiccomments on the regulatory alternativesoutlined in the PRIA.

B. Factors Considered in DevelopingThis Analysis

This final rule requires all juiceprocessors (as defined in the rule),regardless of size, to implement aHACCP program with a 5-log reduction(that is, a 100,000-fold reduction inpathogens) performance criterion. In theproposed rule, FDA tentativelyexempted retailers. In addition, FDAtentatively decided to exempt asretailers very small businesses thatmake juice on their premises and whosetotal sales of juice and juice products donot exceed 40,000 gallons per year andwho sell directly to consumers andother retailers. Based on the commentsand other information, FDA hasdetermined that it is necessary to coversuch very small businesses. Theestimated benefits and costs for this

final rule reflect this change in thecoverage of the rule.

Table 1 gives the time to the effectivedates by size of firm in terms of timefrom the date of publication of this finalrule.

TABLE 1.—TIME TO EFFECTIVE DATEBY SIZE OF FIRM

Firm sizeTime toeffective

date

Large firms ............................ 12 months.Small firms ............................ 24 months.Very small firms .................... 36 months.

For purposes of this rule, the agencyis defining large processors as thosewho have more than 500 employees,small processors as those who have lessthan 500 employees and very smallprocessors as those who have: (1) Totalannual sales of less than $500,000, or (2)that have total annual sales of greaterthan $500,000 but total annual foodsales of less than $50,000, or (3) thatemploy fewer than 100 full-timeequivalent employees and annually sellless than 100,000 units of the juice inthe United States.

This rule follows the implementationof the juice labeling rule, which coversjuice that is packaged and has not beensubjected to a 5-log reduction treatment.Because the coverage of the juicelabeling rule and this juice HACCP ruleoverlap, and because to some extentboth rules address microbial hazardsassociated with juice, it is necessary totake into account the benefits and costsestimated for juice labeling to avoiddouble-counting benefits and costs forjuice HACCP.

C. Benefits

This analysis provides estimatedbenefits due to reduced adverse healtheffects. Presented here is a summary ofthe analysis provided for the proposedrule. Comments are addressed, and anychanges from the analysis for theproposed rule are detailed in eachsection as appropriate.

FDA uses the following steps toestimate health benefits:

1. The most significant hazards injuice are described in terms of severityand duration;

2. The hazards are described in termsof resulting health effects and symptomswhen they cause illness;

3. The health effects and symptomsare translated into consumer utilitylosses;

4. The utility losses are translated intovalues in terms of lost dollars (this givesthe cost per case for every combination



of level of severity and for the specifiedduration for each hazard);

5. The average annual number ofreported cases associated with juicecovered by this final rule are listed;

6. The factors used to account forunder reporting of foodborne illness areexplained;

7. The estimates of the average annualnumber of cases are given;

8. The estimated number of cases isdivided according to level of severity;

9. The percentages of each type ofhazard expected to be prevented by theproposal are listed; and

10. The total health benefits of theproposal are derived by multiplyingsteps 4, 7, and 8.

That is, TB = RC x CF x CR x V, whereTB = total health benefits in dollars,RC = number of reported cases,CF = under reporting correction factor,CR = percent of cases reduced,V = dollar value per case averted

(medical costs + value of pain andlost function).

One comment stated that FDA hadunderestimated the amount of untreatedjuice consumed and, therefore, hadunderestimated the number of cases ofillness associated with juice. FDAdisagrees that the cases of illnessaddressed by the rule have beenunderestimated due to incorrectconsumption estimates. FDA did notestimate the number of illnesses basedon consumption. Instead, the agencyestimated the number of illnesses bymultiplying confirmed illnessesassociated with juice by factorsaccounting for under-reporting offoodborne illness. Thus, FDA does notagree with this comment.

One comment questioned the modelused to calculate benefits and asked ifit has been ‘‘calibrated.’’ The commentdid not explain how the word calibratedis used in this case. FDA assumed thatit meant to compare the estimatesobtained using this model with theactual number of illnesses related tojuice. FDA has used this model tocalculate benefits for rules involvingmicrobial hazards since 1994. Themodel is an adaptation of peer-reviewedresearch on estimating the costs ofillness and injury (Ref. 74). The modelis the best method known to FDA forestimating the benefits of rulesinvolving microbial hazards, and issimilar to that used by FSIS for similarrules. Because the actual number ofcases of illness is not observable, it isnot possible to compare the model’sestimates to the actual number ofillnesses.

1. Description of Microbial Hazards inJuice

The most significant health risksassociated with juice products are thosethat result from microbialcontamination. There are other non-microbial potential hazards related tojuice that this rule is designed tocontrol. FDA does not have enough datato quantify benefits for these non-microbial hazards. From 1992 to 1998the hazards associated withcommercially processed, packaged juiceproduced by nonretail establishmentsincluded Bacillus cereus,Cryptosporidium parvum, E. coliO157:H7, and Salmonella non typhi.Most of the information in section C ofthis document (Benefits) is taken from‘‘Appendix: Preliminary Investigationinto the Morbidity and MortalityAssociated with the Consumption ofFruit and Vegetable Juices’’ (Ref. 6, theAppendix). The Appendix includeshazards other than those for whichbenefits have been estimated in thisanalysis. The hazards considered insection C of this document are those forwhich the risk is highest, meaning thatthey are the most significant in terms ofprobability of occurrence and/orseverity of outcome.

Some comments stated that C. parvumshould have been included in theestimate of benefits for the HACCPproposal. The comments cite FDA’sinclusion of C. parvum in the list ofhazards in the Appendix. FDA includedC. parvum as a hazard addressed by thelabeling rule but not as a hazardaddressed by the proposed HACCP rule.The only documented cases of juice-related C. parvum illnesses fromcommercially produced products from1992 to 1996 were from juice producedby processors making less than 40,000gallons per year. Because theseprocessors were included under theretail exemption from the proposedHACCP rule, the proposed HACCP rulewould not have addressed the C.parvum hazard. Because this finalHACCP rule covers all processorsregardless of the volume of juice theyproduce, C. parvum is a hazardaddressed by this final rule.

2. Description of Health Effects andSymptoms of Microbial Hazards in Juice

In order to quantify the loss(disutility) that individuals experiencefrom becoming ill, the pain, suffering,and mobility loss must be scaled.Individuals who become ill suffer lossesof functional status in terms of mobility,ability to do other physical activity, andability to engage in social activities.Individuals who become ill also

experience additional losses from thesymptoms of the illness.

One comment stated that symptomsand functional effects associated withsome cases are more severe than thosedescribed by FDA. FDA agrees with thiscomment. However, it is equally truethat symptoms and functional effectsassociated with some cases are lesssevere than those described by FDA.The symptoms and functional effectsdescribed by FDA were developed withthe assistance of medical doctors at FDAand are those of a typical case for eachlevel of severity for each hazard. Effectsvary to a considerable degree acrosscases of any illness or disease. Suchvariance is not captured by thisanalysis. However, FDA believes thatthe use of typical cases is appropriatefor this analysis.

3. Utility Losses From MicrobialHazards in Juice

Decreases in functional status andsymptoms and problems associated withillness translate into values of disutility.Utility losses for survivors are derivedby multiplying the total disutility perday by the number of days thatsymptoms of the illness persists. Thisgives the utility loss for survivors interms of the number of quality adjustedlife days (QALD’s) for each case of thecategories of severity for each hazard. AQALD is a day of perfect health.

4. Value of Losses From MicrobialHazards in Juice

FDA values a QALD at $630. Thevalue of utility losses for survivorscomes from multiplying the number ofQALD’s lost due to the illness by thevalue of a QALD. This represents thevalue of pain and function losses thatindividuals experience. Additionally,there are the societal costs of medicaltreatment. These costs are sharedgenerally between insurance companiesand individuals. They include allaspects of medical expenses (e.g.,physician visits, laboratory tests,prescriptions and therapies, hospitalstays). The value of losses per case is thesum of the value of utility losses forsurvivors and the medical costs for thecategories of severity for each hazard.

5. Distribution of the Reported Cases perYear for Microbial Hazards in Juice

The analysis for the proposed ruleused the average number of reportedcases from 1992 through 1996 for eachhazard for the types of products coveredby the rule.

Some comments claimed that FDAhad miscalculated the benefits of theHACCP proposal by including outbreaksassociated with non-commercially



produced juice. Although other parts ofthe proposed rule and the Appendixrefer to outbreaks associated with non-commercially produced juice, theestimate of the benefits of the HACCPrule was based only on outbreaksassociated with commercially producedjuice.

Some comments stated that FDA hadmiscalculated the average number of

cases per year. These comments useddata presented in the Appendix torecalculate the average number of casesper year. The comments were confusedbecause the Appendix lists severaloutbreaks that were associated withnon-commercially produced juice.Because this regulation covers onlycommercially produced juice, outbreaks

associated with non-commerciallyproduced juice were not included in thecalculation of the average annualnumber of cases. Thus, the averageannual number of cases was properlycalculated.

Tables 2 and 3 should clarify whichoutbreaks FDA has used in this analysis,and why some outbreaks were not used.

TABLE 2.—JUICE OUTBREAKS (1992 TO 2000) USED TO CALCULATE BENEFITS

Product and year of event Hazard Numberof cases Source of data on event

Orange juice, 1994 ........................................................................ B. cereus .................................. 85 FDA recall data.Orange juice, 1995 ........................................................................ Salmonella spp. ........................ 62 Outbreak data.Apple juice, 1996 .......................................................................... E. coli O157:H7 ........................ 70 Outbreak data.Apple juice, 1996 .......................................................................... E. coli O157:H7 ........................ 14 Outbreak data.Apple juice, 1996 .......................................................................... C. parvum ................................. 31 Outbreak data.Apple juice, 1996 .......................................................................... E. coli O157:H7 ........................ 1 Pennsylvania State Health

Dept.Orange juice, 1999 ........................................................................ Salmonella muenchen .............. 423 Outbreak data.Apple juice, 1999 .......................................................................... E. coli O157:H7 ........................ 9 Oklahoma State Health Dept.Orange juice, 2000 ........................................................................ Salmonella enteritidis ............... 88 Outbreak data.

TABLE 3.—JUICE OUTBREAKS (1992 TO 2000) NOT USED TO CALCULATE BENEFITS

Product and year ofevent Hazard Number of cases Source of data on

event Reason not included

Orange juice MixingCompound, 1992.

Salmonella agona ...... 25 ............................... FDA recall Data ......... Orange Julius compound is mixed with juiceat the retail location but does not containjuice.

Apple juice, 1993 ....... C. parvum .................. 160 ............................. Outbreak Data ........... Juice not made by commercial establish-ment.

Juice flavored Drinks,1993.

C. parvum .................. Unknown .................... FDA recall Data ......... Approved municipal water supply was con-taminated, rule not expected to preventsuch occurrences.

Carrot juice, 1993 ...... Clostridium botulinum 1 ................................. Washington StateHealth Dept.

Home-made product.

Orange juice, 1993 .... Unknown .................... 23 ............................... Ohio State HealthDept.

Contamination likely caused by consumer.

Watermelon Juice,1993.

S. spp. ........................ 18 ............................... Florida State HealthDept.

Home-made product.

Apple juice, 1996 ....... E. coli 157:H7 ............ 6 ................................. Outbreak data ............ Juice not made by Commercial establish-ment.

Some comments claimed that FDA’sanalysis had not taken into account theefforts to control hazards made by theindustry after the October 1996outbreak. To estimate the number ofillnesses that the proposed rule wouldprevent, FDA used the most recent 5-year period for which final CDCnumbers were available. In the analysisof the proposed rule, FDA did notinclude 1997 in the estimate of illnessesthat the rule would prevent becausethere was too great of a possibility thatillnesses that had actually occurred hadnot yet been reported. FDA can now addthe 1997 to 2000 experience to the 1992to 1996 experience. By doing so FDAaddresses this comments concern. Theaverage number of cases reported peryear for each hazard is described intable 4.

TABLE 4.—AVERAGE REPORTEDCASES PER YEAR FOR MICROBIALHAZARDS IN JUICE (1992 TO 2000)

HazardAverage No. ofcases reported

per year

B. cereus ........................ 2C. parvum ....................... 3E. coli O157:H7 .............. 10Salmonella (non-typhi) .... 64

6. Estimates of Factors Needed To OffsetUnderreporting of Foodborne Illness

It is widely recognized that the totalnumber of foodborne illnesses is muchgreater than those numbers reported tothe CDC. In order to compensate for therate of underreporting, the number ofknown cases associated with a hazard

(i.e., reported to CDC) is multiplied byfactors that are estimated to account forunderreporting.

One comment took issue with theunderreporting correction factors usedby FDA. The comment stated that nounderreporting correction factor shouldever exceed 100. In the analysisaccompanying the proposed rule, FDAused two estimates of underreportingcorrection factors that have been widelycited on this issue. FDA does not agreethat underreporting correction factorsshould never exceed 100. Theappropriate correction factors are thosebased on the best information available,without any limit created by apredetermined number.

Since the PRIA, CDC has publishedestimates of foodborne illness; in thisfinal estimate of costs and benefits, FDA



is relying on these recent CDC estimates.The estimates of underreportingcorrection factors used in the PRIArelied heavily on research that was over20 years old. In some cases, the researchpreceded the recognition that E. coliO157:H7 was a pathogen. The correctionfactors based on this research requireda significant amount of adaptation,extrapolation and interpolation by FDA.By relying on the recent CDC estimatesof foodborne illness to determinecorrection factors, FDA is reducing itsreliance on dated research and its ownextrapolations. FDA believes that theestimates of benefits based on CDCestimates of foodborne illness should bemore objective.

The underreporting correctiion factorscalculated from the CDC reported byMead et al, show the relationshipbetween estimated total cases andculture-confirmed total cases. Thefactors are based on surveys estimatingthe probability that: (1) A person whobecomes ill seeks medical care, and (2)the probability that the physician willobtain a stool culture from the person,and (3) the probability that thelaboratory will test for the pathogen.The factor for a particular pathogen isthe inverse of the multiplicative productof those three probabilities. FDA isrelying on the CDC point estimates ofthe average number of cases per yearand the CDC underreporting factor.Because CDC did not provide ranges forthese estimates, FDA has insufficientinformation to probide a range ofestimates for the benefits of this rule.FDA’s use of a point estimate for thenumber of illnesses should not,however, be interpreted as implying theabsence of uncertainty about theseestimates.

For two of the hazards in thisanalysis, E. coli O157:H7 andSalmonella, FDA has used correctionfactors based on the ratio of totalestimated cases to active surveillancecases estimated. FDA has used thesefactors for these hazards because thejuice outbreaks for these hazardsassociated with this rule were

discovered through the activesurveillance of the FoodNet system. TheFoodNet system is designed to identifyinterstate outbreaks and to morethoroughly discover cases associatedwith an outbreak.

For B. cereus FDA has used acorrection factor based on the ratio oftotal estimated cases to reportedoutbreak cases. FDA has used this factorfor this hazard because the juiceoutbreaks for this hazard associatedwith this rule were discovered throughthe standard outbreak reporting process.B. cereus is not a hazard tested for in theFoodNet system, and because of its mildsymptoms is very likely to beunderreported.

For C. parvum FDA has used acorrection factor based on the ratio oftotal estimated cases to 10 percent of theestimated passive surveillance cases.According to CDC, reported outbreakcases account for only 10 percent of thecases accounted for through passivesurveillance. FDA has used this factorfor C. parvum because the juiceoutbreaks for this hazard associatedwith this rule were discovered throughthe standard passive surveillanceprocess. C. parvum is not a hazardtested for in the FoodNet system, nor isit on the list of hazards reportable toCDC. Because of its mild symptoms it isvery likely to be underreported.

The correction factors used in thisanalysis are given in table 5.

TABLE 5.—ESTIMATES OF FACTORSNEEDED TO OFFSET UNDER-REPORTING OF FOODBORNE ILLNESS

Hazard Correction factor

B. cereus ........................ 380C. parvum ....................... 1,071E. coli O157:H7 .............. 20Salmonella (non-typhi) .... 38

7. Estimates of Juice-Associated CasesPer Year

In table 6, FDA has estimated rangesof the likely annual number of cases thatoccur for each of the four pathogensstudied.

TABLE 6.—ESTIMATE OF JUICE-ASSO-CIATED CASES COVERED PER YEAR

Hazard Case

B. cereus ........................ 3,420C. parvum ....................... 3,210E. coli O157:H7 .............. 200Salmonella (non-typhi) .... 2,430

8. Estimate of Juice-Associated Casesper Year Not Prevented by LabelingRule

FDA estimated that the juice labelingrule would prevent up to 140 juice-associated illnesses (10 C. parvum, 40 E.coli, 90 Salmonella) as consumers avoidconsumption of untreated juice. ThisHACCP rule will effectively supersedethe labeling rule for all those processingestablishments covered by the labelingrule. Therefore, once it goes into effect,the HACCP rule will be responsible forprevented juice-related illnesses and notthe labeling rule. However, this analysisshould attribute to the juice HACCP ruleprevention of only those illnesses thatwould not have been prevented by thejuice labeling rule had this rule notsuperseded it. To estimate the potentialbenefits of this HACCP final rule, FDAsubtracted 140 cases that were estimatedto be prevented by the labeling rule(assuming that 16 percent of consumersread the label and do not consumeuntreated juice) from the estimatesprovided in table 6. The 16 percentconsumer response estimates are thelargest estimates of consumer responsethat FDA has made for the juice labelingrule. Therefore, subtracting the 16percent consumer response estimatesfrom the estimates of the total numberof juice-related illnesses yields thelowest number of illnesses that may beprevented by this juice HACCP finalrule. Table 7 gives estimates of thenumber of juice-related illnesses peryear not prevented by the juice labelingrule. The estimates in table 7 come fromsubtracting the estimated 140 casesprevented by the labeling rule from theestimated cases in table 6.

TABLE 7.—THE ESTIMATED NUMBER OF JUICE-ASSOCIATED CASES NOT PREVENTED BY THE LABELING RULE DIVIDEDACCORDING TO LEVEL OF SEVERITY

Hazard Severity Percent Cases

Mild .................................................................................. 99 3,390Moderate ......................................................................... 1 30Severe ............................................................................. .03 1

B. cereus .......................................................................... Total cases ...................................................................... 100 3,421Mild .................................................................................. 90 2,890Moderate ......................................................................... 9 290Severe ............................................................................. .7 20Death ............................................................................... .02 1

C. parvum ........................................................................ Total cases ...................................................................... 100 3,200



TABLE 7.—THE ESTIMATED NUMBER OF JUICE-ASSOCIATED CASES NOT PREVENTED BY THE LABELING RULE DIVIDEDACCORDING TO LEVEL OF SEVERITY—Continued

Hazard Severity Percent Cases

Mild .................................................................................. 59 95Moderate ......................................................................... 38 60Severe-acute ................................................................... 3 5Severe-chronic ................................................................ 4 10Death ............................................................................... .0 0

E. coli O157:H7 ............................................................... Total cases ...................................................................... 100 160Mild .................................................................................. 68 1,590Moderate ......................................................................... 31 730Severe ............................................................................. 1 20ReA-short term ................................................................ 2 50ReA-long term ................................................................. 5 120Death ............................................................................... 5 120

Salmonella (non typhi) ..................................................... Total cases ...................................................................... 100 2,340

9. Percent of Cases Preventable byHACCP Proposal

Table 8 indicates the percent of casesfor each hazard expected to beprevented by the rule. In general, mostpathogens will be eliminated when a 5-log treatment is applied. For example, E.coli O157:H7, C. parvum andSalmonella should all be completelyeliminated from juice by standardmethods of flash pasteurization (in theabsence of extraordinarily high counts,detrimental human intervention, orequipment failure). However, hazardsassociated with B. cereus will notnecessarily be eliminated by heattreatment. This bacterium forms sporesthat are more difficult to kill by theusual heat process applied to juice.

In the proposed rule, FDA tentativelyexempted certain small retail

processors. FDA estimated that theexemption for small retail processorswould affect 14 percent of the volumeof unpasteurized juice. Therefore, theagency estimated that though pathogencontrols may be 100 percent effective incontrolling some hazards, such controlswould only prevent 86 percent of thecases of illness from these hazards,because of the 14 percent of juice notcovered. The final rule covers allprocessors of juice as defined in thefinal rule; therefore, controls will affectthe full volume of juice made byprocessors. (Retailers are not covered bythis rule. Retailers are those businessesthat sell only direct to consumers andinclude grocery stores, supermarkets,farms, roadside stands, restaurants, andeating places.)

TABLE 8.—PERCENT OF CASESPREVENTABLE BY HACCP PROPOSAL

HazardPercent of casespreventable by

HAACP proposal

B. cereus ........................ 10C. parvum ....................... 100E. coli O157:H7 .............. 100Salmonella (non typhi) .... 100

Table 9 indicates the number of casesfor each hazard expected to beprevented by the rule.

TABLE 9.—ESTIMATES OF JUICE-ASSOCIATED CASES PER YEAR PREVENTED BY HACCP RULE

Hazard Severity Percent ofcases Cases

Mild .................................................................................. 99 340Moderate ......................................................................... 1 0Severe ............................................................................. .3 0

B. cereus .......................................................................... Total case ........................................................................ 100 340Mild .................................................................................. 90 2,890Moderate ......................................................................... 9 290Severe ............................................................................. 7 20Death ............................................................................... .02 1

C. parvum ........................................................................ Total cases ...................................................................... 100 3,200Mild .................................................................................. 59 95Moderate ......................................................................... 38 60Severe-acute ................................................................... 3 5Severe-chronic ................................................................ 4 10Death ............................................................................... .08 0

E. coli O157:H7 ............................................................... Total cases ...................................................................... 100 160Mild .................................................................................. 68 1,590Moderate ......................................................................... 31 730Severe ............................................................................. 1 20ReA–short term ............................................................... 2 50ReA–long term ................................................................ 5 120Death ............................................................................... .04 1

Salmonella (non typhi) ..................................................... Total cases ...................................................................... 100 2,340



10. Estimates of Annual Benefits forHACCP Proposal

The total benefits for the categories ofseverity for each hazard are derived bymultiplying the number of casesprevented by this rule by the estimatesof the value of utility losses and medicalcosts per case. The sum of those benefitsfor each hazard is the total benefits ofthis rule for pathogen control. Table 10gives the estimate of benefits for eachhazard.

TABLE 10.—ESTIMATES OF JUICE-ASSOCIATED CASES PER YEAR PRE-VENTABLE BY HACCP RULE

Hazard Severity Dollars

Mild .............. $102,000B. cereus ...... Total ............. 102,000

Mild .............. 5,780,000Moderate ...... 1,450,000Severe ......... 360,000Death ........... 5,000,000

C. parvum .... Total ............. 12,590,000Mild .............. 190,000Moderate ...... 240,000Severe-acute 165,000Severe-

chronic.12,210,000

E. coliO157:H7.

Total ............. 12,805,000

Mild .............. 1,590,000Moderate ...... 1,460,000Severe ......... 320,000ReA-short

term.350,000

ReA-longterm.

117,120,000

Death ........... 5,000,000Salmonella

(non typhi).Total ............. $125,840,000

Table 11 presents the estimate ofannual benefits based on table 10.

TABLE 11.—ESTIMATES OF ANNUALMICROBIALLY RELATED BENEFITSFOR HACCP PROPOSAL

Hazard Dollars

B. cereus ........................ $102,000C. parvum ....................... 12,590,000E. coli O157:H7 .............. 12,805,000Salmonella (non typhi) .... $125,840,000

Total ............................ 151,000,000

11. Pesticide ResiduesThere are two potential benefits

associated with the regulation ofpesticides: (1) Decreases in cancer andother illness caused by chronicconsumption of pesticide residues and,(2) social benefits associated withreductions in the costs of recapturingfirm goodwill. FDA cannot quantify thecost savings that will occur because ofmore vigilant monitoring of pesticideresidues by firms under a HACCP rule.

12. Summary of BenefitsTable 12 summarizes the benefits of

this rule.

TABLE 12.—BENEFITS OF JUICEHACCP RULE

Type of benefit Annual value

Reduced illness anddeath from Control-ling pathogens.

$151 million.

Reduced harm fromphysical and chem-ical hazards.

Not quantified, effectsoften long-term andprobably small.

Total Quantified Ben-efits.

$151 million

D. CostsThe costs of these rules have been

estimated by multiplying the costs foreach proposed requirement on a per-plant basis by the number of plantsaffected by each requirement. Cost perplant will vary by current practice,product, and size.

1. CoverageIn the proposal, FDA tentatively

decided that retailers would includeprocessors that are very smallbusinesses, that make juice on theirpremises, and that directly sell juice orjuice products to consumers and otherretailers—provided that retail sales ofjuice and juice products do not exceed40,000 gallons per year. As noted, FDAhas decided in the final rule not toexclude such processors from the rule’srequirements. The final rule covers allprocessors of juice except those who areretailers. Retailers are those businessesthat sell only direct to consumers andinclude grocery stores, supermarkets,

farms, roadside stands, restaurants, andother eating places.

Since FDA published the proposedrule, it collected data showing that 24percent of very small apple juiceprocessors only sell juice direct toconsumers. FDA assumes that the samepercentage of very small orange juiceprocessors only sell juice direct toconsumers. Therefore, about 380 verysmall apple and 70 very small orangejuice processors are exempted from therule as retailers.

FDA estimated that 5 percent (about50 plants) of the 900 plants in the FDAOfficial Establishment Inventory (OEI)would have implemented HACCP asrequired by this rule by the effectivedate of the rule even if FDA had notdone this rulemaking. No HACCP costsare attributable to this rule for theseplants.

Table 13 shows the estimated numberof establishments affected by the rule.These numbers exclude the retailers andthe 5 percent of plants already doingHACCP.

TABLE 13.—NUMBER OF PLANTSAFFECTED BY THE RULE

Plant typeNumber of

establishmentsaffected

Juice manufacturers inthe OEI ........................ 850

Very small apple juicemakers ........................ 1,220

Very small orange juicemakers ........................ 230Total ............................ 2,300

2. Length of Production Period

The agency has assumed that 50percent of the 850 plants in the OEI plusall of the 1,450 very small juice makersaffected by the HACCP rule produceseasonally. Table 14 shows the length ofthe production period for plantsproducing seasonally and year round.

TABLE 14.—PLANTS’ PRODUCTION PERIOD

Weeks ofoperationper year

Hours ofoperationper day

Number ofplants

Seasonal .................................................................................................................................................. 16 12 1,875Year Round .............................................................................................................................................. 52 24 425

Total ..................................................................................................................................................... 2,300



3. Cost Estimates by Requirement

a. HACCP costs.i. CGMP’s (§ 120.5)ii. Prerequisite Program SOP’s (§ 120.6)iii. Hazard Analysis (§ 120.7)iv. HACCP Plan (§ 120.8)v. Corrective Actions (§ 120.10)vi. Verification and Validation

(§ 120.11)vii. Process Verification for Certain

Citrus Processors(§ 120.25)viii. HACCP Records (§ 120.12)ix. Training (§ 120.13)x. Imports and Foreign Processors

(§ 120.14)b. Summary of Costs.c. Take First Year and Recurring Cost

Per Activity.a. HACCP costs.—i. CGMP’s (§ 120.5).

No costs are attributed to this section forthis rulemaking. In 1996, only 6 percentof the plants inspected were cited forofficial action. Thus, an overwhelming

majority of firms are complying withpart 110. Therefore, there is noadditional cost of complying with thisprovision because plants are alreadycomplying with part 110. Therefore,FDA assumed that this rule will have noeffect on the enforcement of the CGMP’sfor juice products.

ii. Prerequisite program SOP’s(§ 120.6).—Developing SOP’s. The costper plant of developing SOP’s isapproximately $260. If one half of the850 domestic plants in the OEI and allof the 1,450 very small juice processorsdo not currently have SOP’s, then theywill have to develop them to complywith this regulation. Under theseassumptions, the total cost for theindustry to develop SOP’s isapproximately $488,000 ($260 x 1,875plants).

Implementing sanitation controls withcorrections of deviations from SOP’s.

Based on information from inspectionreports, FDA assumes that about 30percent of all 2,300 covered juice plants(about 690 plants) are likely to havesanitation controls that areinsufficiently implemented, but whichdo not warrant administrative orregulatory action. If it costs each ofthese 690 plants $500 to implementsanitation controls and to correctdeviations from SOP’s earlier than theywould do otherwise, then the total costfor this requirement is $345,000.Because this cost is discounted, it isadded as a one-time expenditure in thetotal costs.

Monitoring and documenting ofSOP’s. Table 15 shows the distributionof per plant and total industry costsbased on the estimate in table 25 forSOP monitoring and documentingneeded to comply with this rule.

TABLE 15.—TOTAL ANNUAL COST OF SOP MONITORING AND DOCUMENTING

Annual perplant SOP

monitoring anddocumenting

cost

Number ofplants

Annual SOPmonitoring anddocumenting

cost

Seasonal ...................................................................................................................................... $100 1,662 $166,000Year round ................................................................................................................................... 340 213 72,000

Totals .................................................................................................................................... 1,875 238,000

iii. Hazard analysis (§ 120.7). FDAestimates that performing a hazardanalysis takes 20 labor hours. At $13 perlabor hour the cost of performing ahazard analysis is about $250 per plant.Approximately 2,300 plants will need toperform a hazard analysis to complywith this rule. Therefore, the total costto perform a hazard analysis isapproximately $575,000.

iv. HACCP plan (§ 120.8)—HACCPplan development. FDA estimates thatdeveloping a HACCP plan takes 60 laborhours. At $13 per labor hour the cost ofdeveloping a HACCP plan is about $750per plant. Only those plants thatdetermine from their hazard analysisthat they have hazards that arereasonably likely to occur will have todevelop a HACCP plan.

Processors that produce shelf-stable orjuice concentrate may conclude aftertheir hazard analysis that they need notinclude pathogen control in any HACCPplan as required by § 120.24(a), if theyinclude a copy of the thermal process intheir written hazard analysis. Theseprocessors only need a HACCP plan ifthey have other hazards that arereasonably likely to occur.

Table 16 shows those processorsexpected to develop HACCP plans.

Adding the categories of processorsthat develop HACCP plans yields a totalof about 1,560 out of the original 2,300processors that perform a hazardanalysis. This may be a smalloverestimate because some of the citrusprocessors that now do not make self-stable products may begin to do sobecause of this rule. It also may be asmall overestimate because of the smallpotential for overlap among thecategories.

TABLE 16.—NUMBER OF PLANTS WITHHACCP PLANS

Processors with pathogen Hazards 1,460Processors with natural toxin Haz-

ards ............................................... 20Processors with pesticide Hazards .. 80

Total processors with HACCPPlans ...................................... 1,560

Approximately 1,560 plants will needto develop a HACCP plan at a cost of$750 each to comply with this rule.Therefore, the total cost to developHACCP plans is approximately$1,170,000.

Pathogen controls. In response to thisrule, many processors that are not now

heat-treating their products are likely tobegin doing so. Processors may chooseany lawful means to achieve therequired 5-log reduction. However, costshere are estimated for pasteurization asthe lowest-cost technology nowavailable.

In the PRIA FDA estimated that costsfor initiating pasteurization range from$18,000 for a very small seasonaloperation to $35,000 for a larger yearround operation. FDA received manycomments claiming that the initial costfor initiating pasteurization was $30,000even for a small operation. Because ofthe number of comments claiming thatthe initiation of pasteurization wouldcost $30,000 for a small operation, FDAhas used a range for its estimate of thecost of initiating pasteurization for verysmall processors.

Of the 2,300 processors covered bythe HACCP rule only a portion of thesewill need to initiate pasteurization. Inthis final rule, processors of shelf-stablejuice and juice concentrate will notneed to incur additional costs for thecontrol of pathogens. FDA estimates thatthis new provision in the final ruleapplies to about 600 processors (70percent of the processors listed in theOEI) affected by this rule.



FDA estimates that all but 20 of therest of the affected processors listed inthe OEI (230 plants) and 30 percent ofthe 1,220 very small apple juiceprocessors (370 plants) are alreadyoperating pasteurization equipment.Therefore, 600 plants do not need toimplement additional pathogencontrols.

For the purpose of this analysis, FDAhas concluded that it is unlikely thatfresh orange juice processors will haveto pasteurize their products to achievea 5-log reduction when a HACCPprogram is adopted because of thenature of the fruits, the availability ofeffective surface treatments and themethods of juice extraction commonlyused by industry. However, given theinformation gained from the December1999 NACMCF meeting on citrus juice

and the several recent outbreaksassociated with fresh citrus juice, it isclear that most fresh orange processorswill need to incur additional costs toimplement effective 5-log pathogenreduction controls. In the PRIA, FDAestimated that costs for these processorswere limited to the costs of creating andoperating a HACCP system withappropriate monitoring andrecordkeeping of the necessary CCP’s,not to purchasing pasteurizingequipment. In this final analysis, FDA isestimating costs for fresh orange juiceprocessors to improve pathogencontrols. Although the measures toimprove such controls will notnecessarily be pasteurization, FDA isestimating these costs to be equivalentto the costs for initiating pasteurization.FDA only has cost data for

pasteurization which is also the onlywidely-adopted commerical technologyfor controlling pathogens in juice. Citrusprocessors may choose to adopt atechnology more expensive that the$18,000 to $30,000 estimated here forthe implementation of pasteurization.However, the more expensivetechnologies would likely be adoptedfor reasons other than compliance withthis rule.

Therefore, 20 affected processorslisted in the OEI, 300 very small citrusprocessors and 850 very small applejuice processors (a total of 1,170 plants)will incur costs to implement additionalpathogen controls. Table 17 shows thefirst year total cost of pathogen controlattributable to the HACCP rule.

TABLE 17.—FIRST YEAR COST OF PATHOGEN CONTROL ATTRIBUTABLE TO HACCP PROPOSAL

Processor type Cost per plant Number ofplants Total

Very small apple juice processors ....................................................................................... $18,000–$30,000 850 $15,300,000–25,500,000

Very small orange juice processors .................................................................................... 18,000–30,000 300 5,400,000–9,000,000

Juice processors in the OEI ................................................................................................ 35,000–58,000 20 700,000–1,160,000

Total .............................................................................................................................. .............................. 1,170 21,400,000–35,660,000

Pasteurization will require ongoingcosts for operation and maintenance.FDA estimates these annual costs for

labor, utilities, and materials subsequentto the first year to be $7,000 per year forvery small processors and $8,000 per

year for processors in the OEI. The totalcost of pathogen control in subsequentyears is given in table 18.

TABLE 18.—SUBSEQUENT YEAR COST OF PATHOGEN CONTROL ATTRIBUTABLE TO HACCP RULE

Processor type Cost per plant Number ofplants Total

Very small apple juice processors ............................................................................................... $7,000 850 $5,950,000Very small orange juice Processors ............................................................................................ 7,000 300 2,100,000Juice processors in the OEI ........................................................................................................ 8,000 20 160,000

Total ...................................................................................................................................... ........................ 1,170 8,210,000

Other costs are related to processingfor pathogen control. The pasteurizationof juice causes changes in thecharacteristics of the products,primarily in terms of texture and taste.Some current consumers of nonheat-treated juice will bear the costs of losinga particular product as well as costs ofsearching for products with thecharacteristics that they prefer. Thus,one cost of these regulations is thelimited loss of ‘‘fresh’’ juice: that is,juice that is not heat (or otherwise)processed.

Some consumer comments indicateda strong preference for fresh juice;

however, although FDA expressly askedfor comments on this issue in itsNovember 1999 notice, no commentssuggested any means of estimating thiscost. FDA has no information on howreadily consumers will acceptpasteurized juice in the place of freshjuice nor does FDA have any otherinformation that could be used toestimate that cost.

Glass and direct food additive HACCPcontrols. FDA has not attributed anycosts for control of glass or unapproveddirect food additives although thesepotential hazards are among those thatare likely to be relevant for juice. The

agency believes that even if broken glassis determined to be a hazard toprocessors packing juice in glass, theseprocessors are already currentlyimplementing every feasible control forthis potential hazard in order to limittheir liability and to provide consumerprotection. Additionally, althoughapproximately 25 percent of theprocessing plants pack juice in glasscontainers, this number is diminishingrapidly for economic and safety reasons.

Regarding food additives, many juiceproducts contain food or color additivesfor the purpose of coloring or extendingproduct shelf life. However the agency



believes that even if unapproved foodadditives are determined to be a hazard,these processors using direct foodadditives in juice are already currentlyimplementing sufficient controls forthese potential hazards as FDA strictlyregulates them.

Natural toxin controls. FDA believesthat in most every case processors ofdomestic apples should be able tocontrol natural toxin hazards such aspatulin, by processing controls such aswashing and culling. This can beaccomplished at no additional cost.

Processors using imported juiceconcentrate are likely to need to initiatea sampling regime for natural toxins.FDA assumes that the 23 large plantswill randomly sample 30 shipments peryear at a cost of $150 per sample. Thetotal marginal cost of patulin testing isapproximately $104,000 (30 tests x$150/test x 23 firms). Costs per plant are$4,500. If any lots are found positive,costs will be incurred for takingcorrective action.

Pesticide controls. FDA believes thatall 175 affected plants operated by largefirms are currently doing a sufficientamount of sampling and monitoring (orreceiving supplier certificates) forpesticides residues. Therefore, FDAassumed that there are no additional

costs for large firms to control thispotential hazard. This does not meanthat FDA believes that no large firmswill identify pesticides as a hazard thatneeds to be controlled under HACCP.Large and small firms are more likelythan very small firms to use importedproduce, which may not be subjected toas strict controls as U.S. produce in allcases. FDA believes that 10 percent ofall large and small firms (80 plants total)will determine that pesticide hazardsare reasonably likely to occur. However,FDA believes that all large firms arealready sufficiently addressing thisissue with present expenditures. FDAmade this estimate based on itsknowledge of the magnitude of thepesticide problem in juice.

If processors determine that pesticideresidues are hazards for their product,then they must run pesticide residuetests to ensure that there are nopesticides either over tolerance or usedon products for which there is notolerance. FDA believes that 10 percentof the shipments received by smallprocessors must be covered by asampling plan. Sixty-five small plantsare believed to cover their shipmentswith a pesticide-sampling plan. Averagecost per plant is estimated to be $1,500.The total annual marginal cost of

pesticide testing is approximately$98,000 (10 tests x $150/test x 65 firms).

v. Corrective actions (§ 120.10).—Corrective action plan. Thedevelopment of a corrective action planfor juice products is less expensive thanrevalidation after each deviation from aCL. FDA estimates that a correctiveaction plan for juice products can bedeveloped in 4 hours with a cost perplant of approximately $50 (about 4hours of management time).

All of the plants that develop HACCPplans as a result of this rule willdevelop corrective action plans tocomply with this rule. The total cost for1,560 plants at $50 each to developcorrective action plans is approximately$78,000.

Corrective actions. Plants operatingunder HACCP plans will take correctiveactions when CL’s are exceeded forhazards such as pesticide residues,unacceptable fruit for pathogen controls,and presence of natural toxins. Costs ofcorrective actions are expected todecline as processors gain moreexperience under a HACCP system andas the number of corrective actionsdecreases. Tables 19 and 20 show theestimated first year and subsequent yearcosts of corrective actions per plant.

TABLE 19.—COST OF FIRST YEAR CORRECTIVE ACTIONS

Plant type Cost per plant Number ofplants Total cost

Seasonal ...................................................................................................................................... $450 1,490 $671,000Year round ................................................................................................................................... 1,460 70 102,000

Totals .................................................................................................................................... 1,560 773,000

TABLE 20.—COST OF SUBSEQUENT YEAR CORRECTIVE ACTIONS


Seasonal ...................................................................................................................................... $110 1,490 $164,000Year round ................................................................................................................................... 340 70 24,000

Totals .................................................................................................................................... 1,560 188,000

Verification and validation (§ 120.11).—Verification. The record verification cost per plant per production cycle isgiven in table 21.

TABLE 21.—COST OF RECORD VERIFICATION


Seasonal ...................................................................................................................................... $420 1,490 $626,000Year Round .................................................................................................................................. 1,350 70 95,000

Totals .................................................................................................................................... ........................ 1,560 721,000

Validation. Processors with HACCPplans must validate their HACCP plans

during the first year afterimplementation and at least annually, or

whenever any changes occur that couldaffect or alter the hazard analysis, or



HACCP plan. Further, processors whohave no HACCP plans because there areno hazards that are reasonably likely tooccur in that process (as may be the casewith processors of shelf-stable orconcentrated juice), the processor must

reassess their hazard analysis when anysignificant change occurs. Examples ofthings that may change include: (1) Rawmaterial specifications or sources of rawmaterials, (2) product formulation, (3)processing methods or systems, (4)

packaging, (5) finished productdistribution systems, or (6) intendedconsumers or use by consumers.

Tables 22 and 23 give the estimatedcost for validation in the first andsubsequent years.

TABLE 22.—COST OF FIRST YEAR VALIDATION

Plant type Number ofvalidations

Cost pervalidation

Number ofplants Total cost

Seasonal Small Business ................................................................................................ 1 $1,000 1,640 $1,640,000Year Round Business ...................................................................................................... 2 1,000 120 240,000Year Round Small Shelf-Stable or Concentrate Business .............................................. 1 1,000 130 130,000Year Round Large Business ........................................................................................... 2 600 80 96,000Year Round Large Shelf-Stable or Concentrate Business ............................................. 1 600 95 57,000

Totals ........................................................................................................................ 2,265 .................... 2,065 $2,163,000

TABLE 23.—COST OF SUBSEQUENT YEAR VALIDATION

Plant type Number ofvalidations

Cost pervalidation


Seasonal Small Business ................................................................................................ 1 $1,000 1,490 $1,490,000Year Round Small Business ............................................................................................ 2 1,000 35 70,000Year Round Large Business ........................................................................................... 2 600 35 42,000

Totals ........................................................................................................................ 1,630 .................... 1,560 1,602,000

vii. Process verification for certaincitrus processors (§ 120.25). Citrusprocessors that decide to rely on surfacetreatments of the fruit to achieve therequisite 5-log reduction (rather thantreating the juice directly) are requiredto sample their final product to verifythe effectiveness of the HACCP plan.These processors are required to testtwo 10 mL subsamples for generic E.coli every 1,000 gallons or every 5 dayswhichever is more frequent. FDAassumes that the cost of testing two 10mL subsamples for generic E. coli is $50.

FDA estimates that there are 240 citrusprocessors that will be affected by thissection. To estimate the number ofsamples, FDA began with the estimatedannual U.S. untreated orange juiceconsumption estimate of 11,700,000gallons. FDA then assumed that 10million gallons were packaged for resaleand therefore covered by this rule. FDAthen assumed that the 180 processorsthat would sample at a frequency ofonce every 5 days on average process750 gallons during that time. Theseprocessors are assumed to be seasonal

processors operating for only 16 weeksa year. FDA made these assumptionsbased on its knowledge of microbialtesting and beliefs about the volume ofuntreated packaged juice sold by smallprocessors. That set of processorsaccounts for 2,160,000 gallons annually.The remaining 60 processors shareproduction of the remaining 7,840,000gallons resulting in about 130 samplesper year per processor.

Table 24 shows the estimated cost forprocess verification sampling for thesecitrus processors.

TABLE 24.—ESTIMATED COST FOR VERIFICATION SAMPLING

Sample frequency Number ofsamples

Number ofprocessors

Cost persample cost Total

Every 5 days .................................................................................................................... 16 180 $50 $144,000Every 1,000 Gallons ........................................................................................................ 130 60 50 390,000

Total .......................................................................................................................... 10,720 240 .................... $534,000

Also, any time that 2 process-verification samples test positive forgeneric E. coli in a series of 7 samplesthere is a process verification failure.The processor must not sell the productwithout further processing and mustreview its monitoring records,reevaluate its HACCP plan, and if noobvious deficiencies in the HACCP planare discovered, must revalidate itsHACCP plan. FDA estimates that even ifall citrus processors that rely on surface

treatments to achieve a 5-log reductionare fully successful in achieving the 5-log reduction, 2 samples in a series of7 will test positive for generic E. colionce in every 1,000 samples. Based onan estimate of 10,720 samples taken peryear, this will occur about 11 times peryear. FDA assumes that the cost offurther processing of the product will bemore expensive than withdrawing anddestroying the product, which shouldnot exceed 1,000 gallons. FDA assumes

that the cost of withdrawing anddestroying the product plus the cost ofreviewing monitoring records,reevaluating and revalidating HACCPplan is $20,000. FDA made thisassumption based on its experiencewith such small lot market withdrawls.Therefore, the additional cost of aprocess verification failure is $220,000per year. The annualized cost of aprocess verification failure is $320 for aseasonal processor sampling every 5



days ((16/1,000) × $20,000 = $320) and$2,600 for a year round processorsampling every 1,000 gallons ((130/1,000) × $20,000 = $2,600).

The total cost of process verificationtesting for untreated citrus juice is$764,000 per year ($534,000 + $220,000= $764,000).

viii. HACCP records (§ 120.12).—Monitoring and recordkeeping. Theadditional monitoring andrecordkeeping that needs to be donethroughout the entire plant is estimatedto be equivalent to 5 percent of oneworker’s time (3 minutes per hour ofoperation per plant). Table 25 shows the

annual cost of additional monitoringand recordkeeping per plant. It alsoshows the distribution of per plant costsand total industry costs for theadditional monitoring andrecordkeeping needed to comply withthis final rule.

TABLE 25.—COST OF MONITORING AND RECORDKEEPING

Plant type Cost per plant Number of plants Total cost

Seasonal .................................................................................................................... $900 1,490 $1,341,000Year Round ................................................................................................................ 5,600 70 392,000

Totals .................................................................................................................. .............................. 1,560 $1,733,000

Record maintenance and storage. The annual cost of record maintenance and storage per plant is described intable 26.

TABLE 26.—COST OF RECORD MAINTENANCE

Plant type Cost per plant Number of plants Total cost

Seasonal .................................................................................................................... $360 1,490 $536,000Year Round ................................................................................................................ 830 70 58,000

Totals .................................................................................................................. .............................. 1,560 $694,000

ix. Training (§ 120.13).—HACCPcoordinator training. Processors mayneed to employ a HACCP coordinator tocarry out the duties specified for sucha person. FDA estimates that the cost ofHACCP coordinator training is $1,300

for each of the 2,300 processing plants,or a total industry cost of $2,990,000.

Employee training in HACCP. Eachprocessor with a HACCP plan will needto train employees in their HACCP-related activities. This analysis assumesthat each plant must train 5 employeesor 10 percent of their employees in

HACCP-related responsibilities,whichever is greater. Table 27 describesthe cost of training each employee for 8hours annually (the equivalent of 40minutes per month for 10 percent of theemployees) and the total cost of thislevel of training.

TABLE 27.—COST OF EMPLOYEE TRAINING

Average plant employmentNumber ofemployees

trained

Cost peremployee


3 ....................................................................................................................................... 3 $100 1,459 $437,7007 ....................................................................................................................................... 5 100 10 5,00015 ..................................................................................................................................... 5 100 19 9,50035 ..................................................................................................................................... 5 100 28 14,00075 ..................................................................................................................................... 8 100 29 23,200175 ................................................................................................................................... 16 100 15 27,000

Totals ........................................................................................................................ 5,160 .................... 1,560 $516,000

x. Imports and foreign processors(§ 120.14).—Importers. The agencyestimates that the cost of these activitieswill be $10,000 for each of the 120importers in the first year, decreasing to$5,000 in subsequent years. Total costsfor importers is $1,200,000 in the firstyear and $600,000 in subsequent years.

Foreign juice processors. Theestimated first year cost per foreign juice

exporter is approximately $26,000, andthe cost in subsequent years is $22,000.Therefore the total cost in the first yearfor 300 foreign processors isapproximately $8 million andapproximately $7 million in subsequentyears. Tables 33 and 34 in theRegulatory Flexibility Analysis, whichfollows, shows typical costs for largeplants that have not already

implemented HACCP. The agencyassumes that these costs arerepresentative of foreign plantsexporting to the United States.

b. Summary of Costs—The totalquantified costs are approximately $44to $58 million in the first year and $23million in all subsequent years. Table 28summarizes costs of the rule byprovision.



C. TABLE 28.—TOTAL FIRST YEAR AND RECURRING COST PER ACTIVITY

Activity First year costs Recurring costs

Develop SOP’s ............................................................................................................................................ $488,000 ..............................Prerequisite Program SOP’s ....................................................................................................................... 345,000 ..............................Monitoring and Documenting for SOP ........................................................................................................ 238,000 238,000Hazard analysis ........................................................................................................................................... 575,000 ..............................HACCP plan ................................................................................................................................................ 1,170,000 ..............................Pathogen controls ........................................................................................................................................ 21,400,000–

35,660,0008,210,000

Natural toxin controls ................................................................................................................................... 104,000 104,000Pesticide controls ......................................................................................................................................... 98,000 98,000Corrective action plan .................................................................................................................................. 78,000 ..............................Corrective actions ........................................................................................................................................ 773,000 188,000Verification ................................................................................................................................................... 721,000 721,000Validation ..................................................................................................................................................... 2,163,000 1,602,000Process verification ...................................................................................................................................... 764,000 764,000HACCP monitoring and recordkeeping ....................................................................................................... 1,733,000 1,733,000Record maintenance and storage ............................................................................................................... 694,000 694,000HACCP coordinator training ........................................................................................................................ 2,990,000 ..............................Employee training ........................................................................................................................................ 516,000 516,000Importers ...................................................................................................................................................... 1,200,000 600,000Foreign processors ...................................................................................................................................... 8,000,000 7,000,000

Totals .................................................................................................................................................... 44,000,000–58,000,000

23,000,000

E. Summary of Benefits and Costs

FDA has examined the benefits andcosts of this rule as required underExecutive Order 12866. Over time, therelationship between benefits and costschanges, so that, to compare themproperly, benefits and costs must bediscounted to the present year (the timeat which the decisions are being made).The quantified benefits (discountedannually over an infinite time horizon at7 percent) are expected to be about $2billion ($151 million/7 percent) and thequantified costs (discounted annuallyover an infinite time horizon at 7percent) are expected to be about $400million.

VI. Regulatory Flexibility AnalysisFDA has examined the impact of this

rule as required by the RegulatoryFlexibility Act (5 U.S.C. 601–612). If arule has a significant impact on asubstantial number of small entities, theRFA requires agencies to analyzeoptions that would minimize theeconomic impact of that rule on smallentities. The agency acknowledges thatthis rule is likely to have a significantimpact on a substantial number of smallentities.

A. ObjectivesThe RFA requires a succinct

statement of the purpose and objectivesof any rule that will have a significantimpact on a substantial number of small

entities. The HACCP rule is being issuedto ensure that juice processors controlall physical, chemical, and microbialhazards in their products.

B. Definition of Small Business andNumber of Small Businesses Affected

The RFA requires a statement of thedefinition of small business used in theanalysis and a description of thenumber of small entities affected.

Table 29 shows the definition of smallbusiness for each type of establishmentaffected and a description of the numberof small entities affected by the rule.The agency has accepted the SmallBusiness Administration (SBA)definitions of small business for thisanalysis.

TABLE 29.—APPROXIMATE NUMBER OF SMALL PLANTS COVERED BY THESE RULES

Type of establishmentNorth American

industry classifica-tion system codes

SBA definition of small by category Category definedas small by SBA

Percent of No. ofsmall businesses

covered

Juice manufacturers in the OEI ............. 311421, 311411 Less than 500 employees ..................... 75% 675Roadside-type apple juice Makers ........ 311421, 311411 Less than 500 employees ..................... 100% 1,220Roadside orange juice Makers .............. 311421, 311411 Less than 500 employees ..................... 100% 230

Totals ..................................................... .............................. ................................................................ .............................. 2,125

C. Description of the Impact on SmallEntities

1. Costs to Small Entities

Because there is a broad distributionof products covered, firm types, currentprocessing practices and sizes, it wouldbe misleading to report average per firmcosts. However, some idea of the costs

can be gained from the followingexamples. The impacts that the costswill have on a firm will vary dependingon the total revenue derived from juiceby a firm and the profit (return on sales)associated with juice production. Dataon food manufacturing firms indicatesthat 75 percent of firms have return onsales of less than 5 percent.

The first example (table 30) is of asmall seasonal apple cider plant that isnow producing nonheat-treated juice,with fruit from a known source, and thathas not developed or implementedsanitation SOP’s. This plant will need tobuy a pasteurizer (or find and validatea different process that achieves a 5-logreduction). The next example (table 31)



is a small plant that is producing orangejuice concentrate year round with fruitfrom a known source, and that hasalready developed and implementedsanitation SOP’s (except that recordshave not been kept on SOP’s). The thirdexample (table 32) is a small plantoperating year round producing

unpasteurized orange juice, usingcommingled fruit, and that has notdeveloped or implemented sanitationSOP’s.

These three illustrative small plantscan be compared to two illustrativelarge plants. The first large plant (table33) is a large shelf-stable apple juiceplant with many employees that

operates year round and that importssome apples and therefore must test forpatulin, and has not developed orimplemented sanitation SOP’s. Thesecond large plant (table 34) is a largeshelf-stable tomato juice processor usingfruit from a known source and withsanitation SOP’s fully implemented.

TABLE 30.—COSTS FOR ILLUSTRATIVE SMALL SEASONAL APPLE CIDER PROCESSOR

Type of cost Cost infirst year

Cost insubsequent years

Develop SOP’s ............................................................................................................................................ $260Sanitation SOP’s .......................................................................................................................................... 500Monitoring and Documenting of SOP’s ....................................................................................................... 100 $100Hazard analysis ........................................................................................................................................... 250HACCP plan ................................................................................................................................................ 750Pathogen controls ........................................................................................................................................ 18,000–30,000 7,900Corrective action plan .................................................................................................................................. 50Corrective actions ........................................................................................................................................ 450 110Verification ................................................................................................................................................... 420 420Validation ..................................................................................................................................................... 1,000 500HACCP monitoring and recordkeeping ....................................................................................................... 900 900Record maintenance & storage ................................................................................................................... 360 360Training of coordinator ................................................................................................................................. 1,300Employee training ........................................................................................................................................ 300 300

Totals .................................................................................................................................................... 24,700–36,700 10,600

TABLE 31.—COST FOR ILLUSTRATIVE SMALL YEAR ROUND CONCENTRATED ORANGE JUICE PROCESSOR

Type of cost Cost in first year Cost insubsequent years

Monitoring and documenting of SOP’s ........................................................................................................ $340 $340Hazard analysis ........................................................................................................................................... 250Validation ..................................................................................................................................................... 1,000Training of coordinator ................................................................................................................................. 1,300

Totals .................................................................................................................................................... 2,900 300

TABLE 32.—COST FOR ILLUSTRATIVE SMALL YEAR ROUND UNPASTEURIZED ORANGE JUICE PROCESSOR


Develop SOP’s ............................................................................................................................................ $260Monitoring and documenting of SOP’s ........................................................................................................ 340 $340Hazard analysis ........................................................................................................................................... 250HACCP plan ................................................................................................................................................ 750Pathogen controls ........................................................................................................................................ 18,000–30,000 7,900Corrective action Plan ................................................................................................................................. 50Corrective actions ........................................................................................................................................ 1,460 340Verification ................................................................................................................................................... 1,350 1,350Validation ..................................................................................................................................................... 2,000 1,000Process verification testing .......................................................................................................................... 7,800 7,800Annualized cost of Process Verification Failure .......................................................................................... 2,600 2,600HACCP monitoring and Recordkeeping ...................................................................................................... 5,600 5,600Record maintenance & storage ................................................................................................................... 830 830Training of coordinator ................................................................................................................................. 1,300Employee training ........................................................................................................................................ 500 500

Totals .................................................................................................................................................... 43,100–55,100 28,300

TABLE 33.—COSTS FOR ILLUSTRATIVE LARGE YEAR ROUND APPLE JUICE PROCESSOR


Develop SOP’s ............................................................................................................................................ $260



TABLE 33.—COSTS FOR ILLUSTRATIVE LARGE YEAR ROUND APPLE JUICE PROCESSOR—Continued


Sanitation SOP’s .......................................................................................................................................... 500Monitoring and documenting of SOP’s ........................................................................................................ 340 $340Hazard analysis ........................................................................................................................................... 250HACCP plan ................................................................................................................................................ 750Natural toxin control ..................................................................................................................................... 4,500 4,500Corrective action plan .................................................................................................................................. 50Corrective actions ........................................................................................................................................ 1,460 340Verification ................................................................................................................................................... 1,350 1,350Validation ..................................................................................................................................................... 1,200 1,200HACCP monitoring and recordkeeping ....................................................................................................... 5,600 5,600Record maintenance .................................................................................................................................... 680 680Record storage ............................................................................................................................................ 150Training of coordinator ................................................................................................................................. 1,300Employee training ........................................................................................................................................ 8,300 8,300

Totals .................................................................................................................................................... 24,000 20,000

TABLE 34.—COSTS FOR ILLUSTRATIVE LARGE YEAR ROUND SHELF-STABLE TOMATO JUICE PROCESSOR


Hazard analysis ........................................................................................................................................... $250Validation ..................................................................................................................................................... 600Training of coordinator ................................................................................................................................. 1,300

Totals .................................................................................................................................................... 2,000 $0

Some comments stated that the rulewould be burdensome on small juiceprocessors and that some processorswould have to cease producing juice.FDA is issuing a tiered, extendedcompliance period giving the smallestfirms the most time to comply with therule. Extending the compliance periodby 1 year for small firms could saveeach one $500 to $31,600 (using a 7percent discount rate). Extending thecompliance period by 2 years for very

small firms could save each one $900 to$61,000 (using a 7 percent discountrate). These savings accrue just fromdelaying the time at which theexpenditures for compliance must takeplace. The amount of savings increasesas the cost of compliance increases. Oneeffect of the cost savings will be toreduce small firm failure. FDA believesthat this extended compliance periodwill provide small firms with significantrelief in the cost of preparing for HACCP

and making necessary changes tocomply with this rule.

2. Professional Skills Required forCompliance

The RFA requires a description of theprofessional skills required forcompliance with this rule. Table 35describes the professional skillsrequired for compliance with thevarious activities required by this rule.

TABLE 35.—PROFESSIONAL SKILLS REQUIRED FOR COMPLIANCE

Required activity Section ofrule Professional skills required for compliance

Developing prerequisite program SOP’s ..... § 120.6 Managers familiar with incoming materials and plant sanitation.Implementing sanitation controls with cor-

rections of deviations from prerequisiteprogram SOP’s.

§ 120.6 Production workers who are able to maintain the sanitation controls as described inthe sanitation SOP’s and supervisors or managers who can determine what correc-tive actions are necessary for deviations from SOP’s.

Monitoring and documenting of prerequisiteProgram SOP’s.

§ 120.6 Production workers who are appropriately trained to monitor and keep records on ob-servations and measurements for prerequisite program SOP’s.

Developing hazard analysis and HACCPplan..

§§ 120.7and 120.8

Supervisors or managers who fulfill the role of HACCP coordinator as well as micro-biologists, chemists, and attorneys.

Implementing pathogen controls ................. § 120.8 Production workers who are appropriately trained to monitor and keep records on ob-servations and measurements at CCP’s.

Implementing pesticide controls .................. § 120.8 Production workers who are appropriately trained to carry out tests, to monitor, and tokeep records on observations and measurements at CCP’s.

Tracking corrective actions .......................... § 120.10 Production workers who are trained to take corrective action described in correctiveaction plans and supervisors or managers who can determine what corrective ac-tions are necessary for deviations from CL’s.

Verification ................................................... § 120.11 Supervisors or managers who fulfill the role of HACCP coordinator.Validation ..................................................... § 120.11 Food scientists or food technologists who can perform a scientific review of the proc-

ess.Process verification ..................................... § 120.25 Microbiologists and production workers who are trained to take process verification

samples and food scientists or food technologists who can perform a scientific re-view of the process in the event of a process verification failure.



TABLE 35.—PROFESSIONAL SKILLS REQUIRED FOR COMPLIANCE—Continued

Required activity Section ofrule Professional skills required for compliance

Monitoring and recordkeeping ..................... § 120.12 Production workers who are appropriately trained to monitor and keep records on ob-servations and measurements at CCP’s.

Record maintenance ................................... § 120.12 Clerical or production workers.HACCP coordinator training coordinator ..... § 120.13 Supervisors or managers who fulfill the role of HACCP.HACCP employee training .......................... § 120.13 Clerical and production workers.Imports ......................................................... § 120.14 Clerical workers as well as supervisors or managers who fulfill the role of HACCP co-

ordinator.

3. Recordkeeping requirements

The RFA requires a description of therecordkeeping requirements of theproposed rule. Table 36 shows the

provisions for which records need to bemade and kept by small businesses, thenumber of small businesses affected, theannual frequency that the records needto be made, the amount of time needed

for making each record, and the totalnumber of hours for each provision inthe first year and then in subsequentyears.

TABLE 36.—SMALL BUSINESS RECORDKEEPING REQUIREMENTS

21 CFR provisions

Number ofsmall enti-

ties keepingrecords

Annualfrequency

Hours perrecord persmall entity

Total hoursfirst year

Totalsubsequent

years

120.6 Monitoring and Recordkeeping of SOP’s .................................... 1,660 16 0.5 13,300 13,300210 52 .................... 5,500 5,500

120.7 Hazard analysis ........................................................................... 2,125 1 20 42,500 0120.8 HACCP plan ................................................................................ 1,930 1 60 115,800 0120.8 Pesticide Controls by Supplier Certificate ................................... 1,700 160 .02 5,400 5,400120.11 Verification ................................................................................. 1,450 16 2 46,400 46,400

380 52 1 8 39,500 39,500120.11 Validation ................................................................................... 1,450 1 2 4 11,600 5,800

380 2 .................... 6,100 3,000120.12 HACCP records ......................................................................... 1,450 1,440 .05 104,400 104,400

380 8,640 .................... 164,200 164,200120.12 Record maintenance ................................................................. 1,450 16 1 23,200 23,200

Totals ................................................................................................ .................... .................... .................... 598,000 431,000

1First year. 2 Subsequent year.

D. Minimizing the Burden on SmallEntities

The RFA requires an evaluation ofany regulatory overlaps and regulatoryalternatives that would minimize thecosts to small entities.

There are two alternatives that theagency has considered to provideregulatory relief for small entities. First,FDA considered and is proposing theoption of exempting some small entitiesfrom the requirements of these rules.Second, FDA considered and isproposing the option of lengthening thecompliance period for small entities.

1. Exempt Small Entities

One alternative for alleviating theburden for small entities would be toexempt them from the provisions of thisrule. FDA proposed to exempt retailerswho, for the purposes of this rule, theagency tentatively decided wouldinclude very small businesses that makejuice on their premises and whose totalsales of juice and juice products do notexceed 40,000 gallons per year and who

sell directly to consumers or directly toconsumers and other retailers.

Revenue from sales of 40,000 gallonsof nonheat treated juice may beapproximately $160,000 with annualprofits ranging from $1,600 to $16,000per year (1 percent to 10 percent). Thisexemption covered most of the verysmall businesses, although less than 15percent of the volume of unpasteurizedjuice. However, packaged products soldby these types of processors are coveredunder the labeling rule.

As detailed in response to comment47, the comments that FDA received onthis exemption were almost entirelycritical of the exemption. Based uponthe comments and other informationavailable to the agency, FDA hasdecided not to finalize this proposedexemption.

2. Extend Compliance Period

FDA is issuing a tiered, extendedcompliance period giving the smallestfirms the most time to comply with therule. Extending the compliance period

by 1 year for small firms could saveeach one $500 to $31,600 (using a 7percent discount rate). Extending thecompliance period by 2 years for verysmall firms could save each one $900 to$61,000 (using a 7 percent discountrate). These savings accrue just fromdelaying the time at which theexpenditures for compliance must takeplace. The amount of savings increasesas the cost of compliance increases.

Additional savings may come assmaller firms learn more efficientcompliance strategies from larger firmsthat must comply earlier and as new,less costly technologies that may beemployed by small firms are developedduring the extended compliance period.FDA is unable to quantify theseadditional savings of the extendedcompliance period although one effectof the cost savings will be to reducesmall firm failure.

FDA believes that this extendedcompliance period will provide smallfirms with significant relief in the costof preparing for HACCP and making



necessary changes to comply with thisrule.

E. Summary

FDA has examined the impact of thisrule on small businesses in accordancewith the RFA. This analysis, togetherwith the rest of the preamble constitutesthe final RFA. FDA has determined thatthis rule is likely to have a significantimpact on a substantial number of smallentities.

VII. Paperwork Reduction Act of 1995

This final rule contains informationcollection provisions that are subject toreview by the Office of Management andBudget (OMB) under the PaperworkReduction Act of 1995 (44 U.S.C. 3501–3520). A description of theseinformation provisions is given belowwith an estimate of the annualrecordkeeping burden. Included in theestimate is the time for reviewinginstructions, searching existing datasources, gathering and maintaining thedata needed, and completing andreviewing each collection ofinformation.

Title: Hazard Analysis and CriticalControl Point (HACCP) Procedures forthe Safe and Sanitary Processing ofJuice—Recordkeeping requirements forprocessors of fruit and vegetable juices

Description: This final rule mandatesthe application of HACCP procedures tofruit and vegetable juice processing.HACCP is a preventative system ofhazard control that can be used by allfood processors to ensure the safety oftheir products to consumers. FDA isfinalizing these regulations because asystem of preventative control is the

most effective and efficient way toensure that these food products are safe.FDA’s mandate to ensure the safety ofthe nation’s food supply is derivedprincipally from the act (21 U.S.C. 321et seq.). Under the act, FDA hasauthority to ensure that all foods ininterstate commerce, or that have beenshipped in interstate commerce, are notcontaminated or otherwise adulterated,are produced and held under sanitaryconditions, and are not misbranded ordeceptively packaged; under 21 U.S.C.371, the act authorizes the agency toissue regulations for its efficientenforcement. The agency also hasauthority under the Public HealthService Act (42 U.S.C. 264) to issue andenforce regulations to prevent theintroduction, transmission, or spread ofcommunicable diseases from one Stateto another other State. Informationdevelopment and recordkeeping areessential parts of any HACCP system.The information collection requirementsof this rule are narrowly tailored tofocus on the development of appropriatecontrols and documenting those aspectsof processing that are critical to foodsafety. Through this final rule, FDA isimplementing its authority undersection 402(a)(4) of the act. Theinformation development andrecordkeeping requirements of this finalrule are likewise an implementation ofsection 402(a)(4) of the act.

Description of Respondents:Businesses and other for-profitinstitutions.

In the Federal Register of April 24,1998, the agency requested commentson the proposed collection ofinformation provisions contained in the

HACCP proposal. One comment wasreceived. This comment asserted thatthe change in sequence in the proposedrule for the last two steps of the sevenprinciples of HACCP is a change thatwill result in many paperwork changes.The seven principles of HACCP havebeen articulated by the NACMCF.

The agency does not agree with thiscomment. Prior to 1997, the NACMCFlisted establishing recordkeeping anddocumentation procedures andestablishing verification procedures asthe sixth and seventh principles ofHACCP; this is the order in which theprinciples are reflected in FDA’sseafood HACCP regulation, part 123.When the NACMCF revised its HACCPprinciples and application guidelines in1997, it reversed the order of the lasttwo steps. Thus, the sequence in part120 for the seven principles of HACCPis identical to the sequence mostrecently outlined by NACMCF. The1997 change does not require a changein the analytical approach or in theinformation to be assembled by juiceprocessors as they apply the HACCPprinciples to their process. The agencydoes not anticipate that there will be aneed for processors to completeadditional paperwork simply becausethere has been a change in the order ofthe seven principles of HACCP orbecause there will be a slight differencein the juice HACCP regulation and theseafood HACCP regulation. It is FDA’sposition that as long as all the essentialelements are present in the writtenHACCP plan, the plan will be complete.

FDA estimates the burden of thiscollection of information as follows:

TABLE 37.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR sections Number ofrecordkeepers

Annualfrequency of

records

Total annualrecords

Hours perrecord Total hours

120.6(a) & 120.12(a)(1) & (b) ............................................ 1,875 1 1,875 4 2 7,500120.6(c) & 120.12(a)(1) & (b) ............................................ 1,875 365 684,375 0.1 68,437.5120.7; 120.10 (a); & 120.12(a)(2), (b) & (c) ...................... 2,300 1.1 2,530 20 50,600120.8 (except monitoring records required under

120.8(b)(7)); & 120.12(a)(3),(b)& (c) .............................. 1,840 1 1,840 60 2 110,400120.8(b)(7) & 120.12(a)(4)(i), & (b) ................................... 1,450 14,600 21,170,000 0.01 211,700120.10(c) & 120.12(a)(4)(ii), & (b) ..................................... 1,840 12 22,080 0.1 2,208120.11(a)(1)(iv); 120.11(a)(2); 120.12(a)(5) ...................... 1,840 52 95,680 0.1 9,568120.11(b) & 120.12(a)(5), & (b) ......................................... 1,840 1 1,840 4 7,360120.11 (c) & 120.12(a)(5) & (b) ......................................... 1,840 1 1,840 4 7,360120.14(a)(2); & 120.14 (c) & (d) ........................................ 308 1 308 4 1,232

Totals First year—476,365.5 Subsequent years—358,465.5

1 There are no capital costs or operating and maintenance costs associated with this collection of information.2 First year only.

The burden estimates in table 37above are based on an estimate of thetotal number of juice manufacturing

plants (i.e., 2,300) affected by this finalrule. Included in this total are 850plants currently identified in FDA’s OEI

plus 1,220 very small apple juicemanufacturers and 230 very smallorange juice manufacturers (see table 13



in section V). The figures in table 36 arederived by estimating the number ofplants affected by each portion of thisfinal rule and multiplying thecorresponding number by the number ofrecords required annually and the hoursneeded to complete the record. Thesenumbers were obtained from theagency’s final RIA prepared for this finalrule.

Moreover, these estimates assume thatevery processor will prepare SSOP’s anda HACCP plan and maintain theassociated monitoring records and thatevery importer will require productsafety specifications. In fact, there arelikely to be some small number of juiceprocessors that, based upon their hazardanalysis, determine that they are notrequired to have a HACCP plan underthis final rule.

Table 37 provides a breakdown of thetotal estimated recordkeeping burdenfor the first year and subsequent years.The estimates in this table have beenreviewed by the agency’s HACCPexperts, who have practical experiencein observing various processingoperations and related recordkeepingactivities.

The information collection provisionsof this final rule have been submitted toOMB for review.

Prior to the effective date of this finalrule, FDA will publish a notice in theFederal Register announcing OMB’sdecision to approve, modify, ordisapprove the information collectionprovisions in this final rule. An agencymay not conduct or sponsor, and aperson is not required to respond to, acollection of information unless itdisplays a currently valid OMB controlnumber.

VIII. Environmental ImpactThe agency has previously considered

the environmental effects of the actionbeing taken in this final rule. Asannounced in the proposed rulepublished in the Federal Register ofApril 24, 1998 (63 FR 20450) (Ref. 2),the agency determined that under 21CFR 25.30(j) this action is of a type thatdoes not individually or cumulativelyhave a significant impact on the humanenvironment. Therefore, neither anenvironmental assessment nor anenvironmental impact statement wasrequired.

(Comment 158) Two comments werereceived in response to the potentialenvironmental impact of this rule. Onecomment stated that ‘‘* * * theextensive recordkeeping requirementsunder the juice proposal will increasepaper consumption significantly, whichwill not be considered ‘environmentallyfriendly.’ ’’ This comment did not

provide evidence to support thisassertion.

FDA agrees that the recordkeepingrequirement in the HACCP final rulemay increase paper consumption.However, the agency disagrees that thisincrease will be significant. The agencybelieves that the paper used for therequired recordkeeping will be a verysmall fraction of the overall amount ofpaper used in the United States.Therefore, this use will not significantlyincrease the production, use anddisposal of paper and, thus, will notresult in significant adverse impacts onthe environment. Additionally, FDAnotes that § 120.12(g) of the final rulepermits records to be maintainedelectronically. When the regulatedentities maintain records electronically,the need for paper is reduced.

(Comment 159) One comment on theproposed rule stated that efforts toachieve 5-log reduction will lead topossible excessive pollution of theenvironment from disposal ofunessential sanitizers. This commentdid not provide evidence to support thisassertion.

The agency has concluded that evenif some increase in the use of sanitizingproducts should result, the productsused would be either registered with theU.S. EPA or regulated by FDA for useon food contact articles under§ 178.1010 (21 CFR 178.1010) or both.Environmental review is part of EPA’spesticide registration process and is partof FDA’s process for listing sanitizingsolutions under § 178.1010. FDAexpects processors to use all sanitizingproducts according to directions onproduct labels and under thesupervision of experienced persons. Useof the sanitizing products in thismanner should ensure that anyincreased use will not result in adverseeffects on the environment.

The agency has concluded that thesecomments on the potential for adverseenvironmental effects will not affect itsprevious determination that this actionwill not have a significant impact on thehuman environment and that anenvironmental impact statement is notrequired.

IX. FederalismFDA has analyzed this final rule in

accordance with the principles set forthin Executive Order 13132. FDA hasdetermined that the rule does notcontain policies that have substantialdirect effects on the States, on therelationship between the nationalgovernment and the States, or on thedistribution of power andresponsibilities among the variouslevels of government (Ref. 75).

Accordingly, the agency has concludedthat the rule does not contain policiesthat have federalism implications asdefined in the order and, consequently,a federalism summary impact statementis not required.

X. ReferencesThe following information has been

placed on display in the DocketsManagement Branch (address above),and may be seen by interested personsbetween 9 a.m. and 4 p.m. Mondaythrough Friday.1. FDA, Department of Health and Human

Services (DHHS), ‘‘Fruit And VegetableJuice Beverages: Notice of Intent toDevelop a HACCP Program, InterimWarning Statement, and EducationalProgram,’’ 21 CFR part 120, 62 FR45593–45596, August 28, 1997.

2. FDA, DHHS, ‘‘Hazard Analysis and CriticalControl Point (HACCP); Procedures forthe Safe and Sanitary Processing andImporting of Juice,’’ proposed rule, 21CFR part 120, 63 FR 20450–20486, April24, 1998.

3. FDA, DHHS, ‘‘Hazard Analysis and CriticalControl Point (HACCP); Procedures forthe Safe and Sanitary Processing andImporting of Juice;’’ extension ofcomment period, 21 CFR part 120, 63 FR37057, July 8, 1998.

4. FDA, DHHS, ‘‘Food Labeling: Warning andNotice Statements; Labeling of JuiceProducts,’’ proposed rule, 21 CFR part101, 63 FR 20486–20493, April 24, 1998.

5. FDA, DHHS,‘‘Food Labeling: Warning andNotice Statements; Labeling of JuiceProducts,’’ 21 CFR part 101, 63 FR37030–37056, July 8, 1998.

6. FDA, DHHS, ‘‘Preliminary RegulatoryImpact Analysis and Initial RegulatoryFlexibility Analysis of the ProposedRules to Ensure the Safety of Juice andJuice Products,’’ preliminary regulatoryimpact anaysis, 21 CFR parts 101 and120, 63 FR 24254–24378, May 1, 1998.

7. FDA, DHHS, ‘‘Food Labeling: Warning andNotice Statements; Labeling of JuiceProducts; Technical ScientificWorkshops; Requests for AdditionalTime to Achieve the Pathogen ReductionStandard,’’ 21 CFR part 101, 63 FR57594–57596, October 28,1998.

8. FDA, DHHS, ‘‘Hazard Analysis and CriticalControl Point (HACCP); Procedures forthe Safe and Sanitary Processing andImporting of Juice: Reopening ofComment Period,’’ 21 CFR part 120, 63FR 69579–69580, December 17, 1998.

9. FDA, DHHS, ‘‘Apple Cider Food SafetyControl: Workshop,’’ 21 CFR part 101, 64FR 34125–34126, June 25, 1999.

10. FDA, DHHS, ‘‘Hazard Analysis andCritical Control Point (HACCP);Procedures for Safe and SanitaryProcessing and Importing of Juice;Availability of New Data andInformation and Reopening of CommentPeriod,’’ 21 CFR part 120, 64 FR 65669–65671, November 23, 1999.

11. FSIS, USDA, ‘‘National AdvisoryCommittee on Microbiological Criteria



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12. NACMCF, ‘‘National Advisory Committeeon Microbiological Criteria for Foods,Meeting on Fresh Citrus Juice; Transcriptof Proceedings,’’ December 8 to 10, 1999,public meeting.

13. Buchanan, R. L., S. G. Edelson, R. L.Miller, and G. M. Sapers,‘‘Contamination of intact apples afterimmersion in an aqueous environmentcontaining Escherichia coliO157:H7,’’Journal of Food Protection,62(5):444–450, 1999.

14. Walderhaug, M. O., S. G. Edelson-Mammel, A. J. DeJesus, B. S. Eblen, A.J. Miller, and R. L. Buchanan, ‘‘Routes ofinfiltration, survival, and growth ofSalmonella enterica serovar hartford andEscherichia coli O157:H7 in oranges,’’Abstract, Presented at InternationalAssociation for Food Protection meeting,August 6 to 9, 2000.

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Web Address: http://vm.cfsan.fda.gov/∼dms/patuguid.html

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31. FDA Enforcement Report and USDA andHeinz news releases for recall #F–095–9of Strained Beginner carrots, andvegetable chicken dinner baby food,December 23, 1998, and October 9, 1998.

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35. Bolster, D., Apple Hill Quality AssuranceProgram and Guidelines, Presentationduring FDA’s Apple Cider Food SafetyControl Workshop, July 15 to 16, 1999.

36. CFSAN, FDA, Hazard Analysis andCritical Control Point (HACCP) PilotProgram for Selected FoodManufacturers; Interim Report ofObservations and Comments, June 19,1996.

36a. Katz, F., and J. Giese, ‘‘Science givesspecialty juice a big slice of the market,’’Journal Food Technology, 52(11):44–48,1998.

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53. Podoski, B.W., FDA Memorandum to theFile. Regulation of Intrastate Fresh Juice,2000.



54. Buchanan, R.L., and M.H. Golden,‘‘Interactions between pH and malic acidconcentration on the inactivation ofListeria monocytogenes,’’ Journal of FoodSafety, 18:37–48, 1998.

55. Buchanan, R.L., and S.G. Edelson, ‘‘pH-Dependent Stationary-Phase AcidResistance Response ofEnterohemorrhagic Escherichia coli inthe Presence of Various Acidulants,’’Journal of Food Protection 62(3):211–218, 1999.

56. Dock, L.L., J.D. Floros, and R. H. Linton,‘‘Heat inactivation of Escherichia coliO157:H7 in apple cider containing malicacid, sodium benzoate, and potassiumsorbate,’’ Journal of Food Protection,63(8):1026–1031, 2000.

57. Parish, M.E., J.A. Narciso, and L. M.Friedrich, ‘‘Survival of Salmonellae inorange juice,’’ Journal of Food Safety,17:273–281, 1997.

58. Jay, J.M. 1996, ‘‘Indicators of FoodMicrobial Quality and Safety,’’ chapter18, pp. 387–395, In Modern FoodMicrobiology, 5th ed., Chapman & Hall,N.Y.

59. FDA, DHHS, ‘‘Guidance for Industry;Guide to Minimize Microbial FoodSafety Hazards for Fresh Fruits andVegetables,’’ 1998.

60. FDA, DHEW, Fish and Seafood Products,Subpart A—Smoked and Smoke-Flavored Fish, final rule, 21 CFR part128a, 35 FR 17401–17402, November 13,1970.

61. FDA Memorandum to Patricia Spitzigfrom Oliver D. Cook, July 11, 1995,concerning relationships betweenconsumer complaints and processcontrols.

62. FDA, DHHS, ‘‘Procedures for the Safe andSanitary Processing and Importing ofFish and Fishery Products,’’ final rule,21 CFR parts 123 and 1240, 60 FR65096–65202, at 65138, December 18,1995.

63. Buchanan, R.L., FDA Memorandum to theRecord, National Advisory CommitteeRecommendations on MicrobiologicalCriteria for Foods, June 15, 1998.

64. FDA, FDA Technical Scientific Workshopon How Citrus Juice Firms Can Achieve5-log Pathogen Reduction. Transcript ofPublic Meeting, November 12, andNovember 19, 1998.

65. FDA, 2000, ‘‘Compilation of Juice/CiderOutbreaks Associated with MicrobialHazards’’ (1974–2000), July 21, 2000.

66. Kautter, D.A., FDA Memorandum to K.Carson, Revised Synopsis of NACMCFDiscussions, March 20, 2000 and October24, 2000.

67. FDA memorandum to Robert Buchananfrom Sherri McGarry and John Sanders,February 23, 2000, concerningSalmonella outbreak associated withorange juice. FDA memorandum fromMaxine Heinitz, August 19, 1999,concerning update to Salmonelladatabase.

68. Larkin, J.W., FDA Memorandum toOPDFB, Microbiological Critical ControlPoint for Certain Shelf-stable andConcentrated Juice Products, September29, 2000.

69. ICMSF, 1988, Microorganisms in Foods 4:Application of the Hazard AnalysisCritical Control Point (HACCP) Systemto Ensure Microbiological Safety andQuality, Blackwell ScientificPublications, Boston, p. 26.

70. FSIS, USDA, ‘‘Pathogen Reduction;Hazard Analysis and Critical ControlPoint (HACCP) Systems,’’ final rule withrequest for comments, 9 CFR parts 304,308, 310, 320, 327, 381, 416, and 417, 61FR 38806–38855, July 25, 1996.

71. Garthright, W. E., S. Chirtel, and Q.Graves, Derivation of Sampling Plan toMeet the Testing Requirement in theJuice HACCP Final Rule for Citrus Juicesthat Rely Solely or in Part on SurfaceTreatments to Achieve the 5-LogReduction Standard, 2000.

72. CFSAN, FDA, Hazard Analysis andCritical Control Point (HACCP) PilotProgram for Selected FoodManufacturers; Second Interim Report ofObservations and Comments, October 31,1997.

73. Kaplan, R. M., J. P. Anderson, and T. G.Ganiats, ‘‘The Quality of Well-beingScale: Rationale for a Single Quality ofLife Index,’’ In Quality of LifeAssessment: Key Issues in the 1990s,edited by Stuart R. Walker and Rachel M.Rosser, pp. 65–94 and 442–444, TheNetherlands: Kluwar AcademicPublishers, 1993.

74. FDA, DHHS, ‘‘Irradiation in theProduction, Processing, and Handling ofFood,’’ final rule, 21 CFR part 179, 65 FR71056–71058, November 29, 2000.

75. Bluhm, L. and B. Podoski, FDAMemorandum to the File, ‘‘FederalismImplications’’—Fresh and ProcessedJuices/State Regulations and Practices,May 17, 2000.

76. Anderson, S., FDA Memorandum to theFile, ‘‘Federalism Implications’’—Rule20–49 of the Florida Department ofCitrus, January 10, 2001.

List of Subjects in 21 CFR Part 120

Foods, Fruit juices, Imports,Reporting and recordkeepingrequirements, Vegetable juices.

Therefore, under the Federal Food,Drug, and Cosmetic Act, under thePublic Health Service Act, and underauthority delegated to the Commissionerof Food and Drugs, 21 CFR chapter I isamended as follows:

1. Part 120 is added to read as follows:

PART 120—HAZARD ANALYSIS ANDCRITICAL CONTROL POINT (HACCP)SYSTEMS

Subpart A—General Provisions

Sec.120.1 Applicability.120.3 Definitions.120.5 Current good manufacturing practice.120.6 Sanitation standard operating

procedures.120.7 Hazard analysis.120.8 Hazard Analysis and Critical Control

Point (HACCP) plan.

120.9 Legal basis.120.10 Corrective actions.120.11 Verification and validation.120.12 Records.120.13 Training.120.14 Application of requirements to

imported products.

Subpart B—Pathogen Reduction120.20 General.120.24 Process controls.120.25 Process verification for certain

processors.

Authority: 21 U.S.C. 321, 342, 343, 346,348, 371, 374, 379e, 381, 393; 42 U.S.C. 241,242l, 264.

Subpart A—General Provisions

§ 120.1 Applicability.(a) Any juice sold as such or used as

an ingredient in beverages shall beprocessed in accordance with therequirements of this part. Juice meansthe aqueous liquid expressed orextracted from one or more fruits orvegetables, purees of the edible portionsof one or more fruits or vegetables, orany concentrates of such liquid orpuree. The requirements of this partshall apply to any juice regardless ofwhether the juice, or any of itsingredients, is or has been shipped ininterstate commerce (as defined insection 201(b) of the Federal Food,Drug, and Cosmetic Act, 21 U.S.C.321(b)). Raw agricultural ingredients ofjuice are not subject to the requirementsof this part. Processors should applyexisting agency guidance to minimizemicrobial food safety hazards for freshfruits and vegetables in handling rawagricultural products.

(b) The regulations in this part shallbe effective January 22, 2002. However,by its terms, this part is not binding onsmall and very small businesses untilthe dates listed in paragraphs (b)(1) and(b)(2) of this section.

(1) For small businesses employingfewer than 500 persons the regulationsin this part are binding on January 21,2003.

(2) For very small businesses thathave either total annual sales of lessthan $500,000, or if their total annualsales are greater than $500,000 but theirtotal food sales are less than $50,000; orthe person claiming this exemptionemployed fewer than an average of 100full-time equivalent employees andfewer than 100,000 units of juice weresold in the United States, theregulations are binding on January 20,2004.

§ 120.3 Definitions.The definitions of terms in section

201 of the Federal Food, Drug, andCosmetic Act, § 101.9(j)(18)(vi), and part110 of this chapter are applicable to



such terms when used in this part,except where redefined in this part. Thefollowing definitions shall also apply:

(a) Cleaned means washed with waterof adequate sanitary quality.

(b) Control means to prevent,eliminate, or reduce.

(c) Control measure means any actionor activity to prevent, reduce toacceptable levels, or eliminate a hazard.

(d) Critical control point means apoint, step, or procedure in a foodprocess at which a control measure canbe applied and at which control isessential to reduce an identified foodhazard to an acceptable level.

(e) Critical limit means the maximumor minimum value to which a physical,biological, or chemical parameter mustbe controlled at a critical control pointto prevent, eliminate, or reduce to anacceptable level the occurrence of theidentified food hazard.

(f) Culled means separation ofdamaged fruit from undamaged fruit.For processors of citrus juices usingtreatments to fruit surfaces to complywith § 120.24, culled means undamaged,tree-picked fruit that is U.S. Departmentof Agriculture choice or higher quality.

(g) Food hazard means any biological,chemical, or physical agent that isreasonably likely to cause illness orinjury in the absence of its control.

(h) Importer means either the U.S.owner or consignee at the time of entryof a food product into the United States,or the U.S. agent or representative of theforeign owner or consignee at the timeof entry into the United States. Theimporter is responsible for ensuring thatgoods being offered for entry into theUnited States are in compliance with allapplicable laws. For the purposes of thisdefinition, the importer is ordinarily notthe custom house broker, the freightforwarder, the carrier, or the steamshiprepresentative.

(i) Monitor means to conduct aplanned sequence of observations ormeasurements to assess whether aprocess, point, or procedure is undercontrol and to produce an accuraterecord for use in verification.

(j)(1) Processing means activities thatare directly related to the production ofjuice products.

(2) For purposes of this part,processing does not include:

(i) Harvesting, picking, or transportingraw agricultural ingredients of juiceproducts, without otherwise engaging inprocessing; and

(ii) The operation of a retailestablishment.

(k) Processor means any personengaged in commercial, custom, orinstitutional processing of juiceproducts, either in the United States or

in a foreign country, including anyperson engaged in the processing ofjuice products that are intended for usein market or consumer tests.

(l) Retail establishment is anoperation that provides juice directly tothe consumers and does not include anestablishment that sells or distributesjuice to other business entities as wellas directly to consumers. ‘‘Provides’’includes storing, preparing, packaging,serving, and vending.

(m) Shall is used to state mandatoryrequirements.

(n) Shelf-stable product means aproduct that is hermetically sealed and,when stored at room temperature,should not demonstrate any microbialgrowth.

(o) Should is used to staterecommended or advisory procedures orto identify recommended equipment.

(p) Validation means that element ofverification focused on collecting andevaluating scientific and technicalinformation to determine whether theHACCP plan, when properlyimplemented, will effectively controlthe identified food hazards.

(q) Verification means those activities,other than monitoring, that establish thevalidity of the HACCP plan and that thesystem is operating according to theplan.

§ 120.5 Current good manufacturingpractice.

Part 110 of this chapter applies indetermining whether the facilities,methods, practices, and controls used toprocess juice are safe, and whether thefood has been processed under sanitaryconditions.

§ 120.6 Sanitation standard operatingprocedures.

(a) Sanitation controls. Each processorshall have and implement a sanitationstandard operating procedure (SSOP)that addresses sanitation conditions andpractices before, during, and afterprocessing. The SSOP shall address:

(1) Safety of the water that comes intocontact with food or food contactsurfaces or that is used in themanufacture of ice;

(2) Condition and cleanliness of foodcontact surfaces, including utensils,gloves, and outer garments;

(3) Prevention of cross contaminationfrom insanitary objects to food, foodpackaging material, and other foodcontact surfaces, including utensils,gloves, and outer garments, and fromraw product to processed product;

(4) Maintenance of hand washing,hand sanitizing, and toilet facilities;

(5) Protection of food, food packagingmaterial, and food contact surfaces from

adulteration with lubricants, fuel,pesticides, cleaning compounds,sanitizing agents, condensate, and otherchemical, physical, and biologicalcontaminants;

(6) Proper labeling, storage, and use oftoxic compounds;

(7) Control of employee healthconditions that could result in themicrobiological contamination of food,food packaging materials, and foodcontact surfaces; and

(8) Exclusion of pests from the foodplant.

(b) Monitoring. The processor shallmonitor the conditions and practicesduring processing with sufficientfrequency to ensure, at a minimum,conformance with those conditions andpractices specified in part 110 of thischapter that are appropriate both to theplant and to the food being processed.Each processor shall correct, in a timelymanner, those conditions and practicesthat are not met.

(c) Records. Each processor shallmaintain SSOP records that, at aminimum, document the monitoringand corrections prescribed by paragraph(b) of this section. These records aresubject to the recordkeepingrequirements of § 120.12.

(d) Relationship to Hazard Analysisand Critical Control Point (HACCP)plan. Sanitation standard operatingprocedure controls may be included inthe HACCP plan required under§ 120.8(b). However, to the extent thatthey are implemented in accordancewith this section, they need not beincluded in the HACCP plan.

§ 120.7 Hazard analysis.(a) Each processor shall develop, or

have developed for it, a written hazardanalysis to determine whether there arefood hazards that are reasonably likelyto occur for each type of juice processedby that processor and to identify controlmeasures that the processor can apply tocontrol those hazards. The writtenhazard analysis shall consist of at leastthe following:

(1) Identification of food hazards;(2) An evaluation of each food hazard

identified to determine if the hazard isreasonably likely to occur and thus,constitutes a food hazard that must beaddressed in the HACCP plan. A foodhazard that is reasonably likely to occuris one for which a prudent processorwould establish controls becauseexperience, illness data, scientificreports, or other information provide abasis to conclude that there is areasonable possibility that, in theabsence of those controls, the foodhazard will occur in the particular typeof product being processed. This



evaluation shall include an assessmentof the severity of the illness or injury ifthe food hazard occurs;

(3) Identification of the controlmeasures that the processor can apply tocontrol the food hazards identified asreasonably likely to occur in paragraph(a)(2) of this section;

(4) Review of the current process todetermine whether modifications arenecessary; and

(5) Identification of critical controlpoints.

(b) The hazard analysis shall includefood hazards that can be introducedboth within and outside the processingplant environment, including foodhazards that can occur before, during,and after harvest. The hazard analysisshall be developed by an individual orindividuals who have been trained inaccordance with § 120.13 and shall besubject to the recordkeepingrequirements of § 120.12.

(c) In evaluating what food hazardsare reasonably likely to occur,consideration should be given, at aminimum, to the following:

(1) Microbiological contamination;(2) Parasites;(3) Chemical contamination;(4) Unlawful pesticides residues;(5) Decomposition in food where a

food hazard has been associated withdecomposition;

(6) Natural toxins;(7) Unapproved use of food or color

additives;(8) Presence of undeclared ingredients

that may be allergens; and(9) Physical hazards.(d) Processors should evaluate

product ingredients, processingprocedures, packaging, storage, andintended use; facility and equipmentfunction and design; and plantsanitation, including employee hygiene,to determine the potential effect of eachon the safety of the finished food for theintended consumer.

(e) HACCP plans for juice need notaddress the food hazards associatedwith microorganisms and microbialtoxins that are controlled by therequirements of part 113 or part 114 ofthis chapter. A HACCP plan for suchjuice shall address any other foodhazards that are reasonably likely tooccur.

§ 120.8 Hazard Analysis and CriticalControl Point (HACCP) plan.

(a) HACCP plan. Each processor shallhave and implement a written HACCPplan whenever a hazard analysis revealsone or more food hazards that arereasonably likely to occur duringprocessing, as described in § 120.7. TheHACCP plan shall be developed by an

individual or individuals who havebeen trained in accordance with§ 120.13 and shall be subject to therecordkeeping requirements of § 120.12.A HACCP plan shall be specific to:

(1) Each location where juice isprocessed by that processor; and

(2) Each type of juice processed by theprocessor. The plan may group types ofjuice products together, or group typesof production methods together, if thefood hazards, critical control points,critical limits, and procedures requiredto be identified and performed byparagraph (b) of this section areessentially identical, provided that anyrequired features of the plan that areunique to a specific product or methodare clearly delineated in the plan andare observed in practice.

(b) The contents of the HACCP plan.The HACCP plan shall, at a minimum:

(1) List all food hazards that arereasonably likely to occur as identifiedin accordance with § 120.7, and thatthus must be controlled for each type ofproduct;

(2) List the critical control points foreach of the identified food hazards thatis reasonably likely to occur, includingas appropriate:

(i) Critical control points designed tocontrol food hazards that are reasonablylikely to occur and could be introducedinside the processing plantenvironment; and

(ii) Critical control points designed tocontrol food hazards introduced outsidethe processing plant environment,including food hazards that occurbefore, during, and after harvest;

(3) List the critical limits that shall bemet at each of the critical control points;

(4) List the procedures, and thefrequency with which they are to beperformed, that will be used to monitoreach of the critical control points toensure compliance with the criticallimits;

(5) Include any corrective action plansthat have been developed in accordancewith § 120.10(a), and that are to befollowed in response to deviations fromcritical limits at critical control points;

(6) List the validation and verificationprocedures, and the frequency withwhich they are to be performed, that theprocessor will use in accordance with§ 120.11; and

(7) Provide for a recordkeeping systemthat documents the monitoring of thecritical control points in accordancewith § 120.12. The records shall containthe actual values and observationsobtained during monitoring.

(c) Sanitation. Sanitation controlsmay be included in the HACCP plan.However, to the extent that they aremonitored in accordance with § 120.6,

they are not required to be included inthe HACCP plan.

§ 120.9 Legal basis.Failure of a processor to have and to

implement a Hazard Analysis andCritical Control Point (HACCP) systemthat complies with §§ 120.6, 120.7, and120.8, or otherwise to operate inaccordance with the requirements ofthis part, shall render the juice productsof that processor adulterated undersection 402(a)(4) of the Federal Food,Drug, and Cosmetic Act. Whether aprocessor’s actions are consistent withensuring the safety of juice will bedetermined through an evaluation of theprocessor’s overall implementation ofits HACCP system.

§ 120.10 Corrective actions.Whenever a deviation from a critical

limit occurs, a processor shall takecorrective action by following theprocedures set forth in paragraph (a) orparagraph (b) of this section.

(a) Processors may develop writtencorrective action plans, which becomepart of their HACCP plans in accordancewith § 120.8(b)(5), by which processorspredetermine the corrective actions thatthey will take whenever there is adeviation from a critical limit. Acorrective action plan that isappropriate for a particular deviation isone that describes the steps to be takenand assigns responsibility for takingthose steps, to ensure that:

(1) No product enters commerce thatis either injurious to health or isotherwise adulterated as a result of thedeviation; and

(2) The cause of the deviation iscorrected.

(b) When a deviation from a criticallimit occurs, and the processor does nothave a corrective action plan that isappropriate for that deviation, theprocessor shall:

(1) Segregate and hold the affectedproduct, at least until the requirementsof paragraphs (b)(2) and (b)(3) of thissection are met;

(2) Perform or obtain a review todetermine the acceptability of theaffected product for distribution. Thereview shall be performed by anindividual or individuals who haveadequate training or experience toperform such review;

(3) Take corrective action, whennecessary, with respect to the affectedproduct to ensure that no product enterscommerce that is either injurious tohealth or is otherwise adulterated as aresult of the deviation;

(4) Take corrective action, whennecessary, to correct the cause of thedeviation; and



(5) Perform or obtain timelyverification in accordance with § 120.11,by an individual or individuals whohave been trained in accordance with§ 120.13, to determine whethermodification of the HACCP plan isrequired to reduce the risk of recurrenceof the deviation, and to modify theHACCP plan as necessary.

(c) All corrective actions taken inaccordance with this section shall befully documented in records that aresubject to verification in accordancewith § 120.11(a)(1)(iv)(B) and therecordkeeping requirements of § 120.12.

§ 120.11 Verification and validation.(a) Verification. Each processor shall

verify that the Hazard Analysis andCritical Control Point (HACCP) systemis being implemented according todesign.

(1) Verification activities shallinclude:

(i) A review of any consumercomplaints that have been received bythe processor to determine whethersuch complaints relate to theperformance of the HACCP plan orreveal previously unidentified criticalcontrol points;

(ii) The calibration of processmonitoring instruments;

(iii) At the option of the processor, theperformance of periodic end-product orin-process testing; except thatprocessors of citrus juice that rely inwhole or in part on surface treatment offruit shall perform end-product testingin accordance with § 120.25.

(iv) A review, including signing anddating, by an individual who has beentrained in accordance with § 120.13, ofthe records that document:

(A) The monitoring of critical controlpoints. The purpose of this review shallbe, at a minimum, to ensure that therecords are complete and to verify thatthe records document values that arewithin the critical limits. This reviewshall occur within 1 week (7 days) of theday that the records are made;

(B) The taking of corrective actions.The purpose of this review shall be, ata minimum, to ensure that the recordsare complete and to verify thatappropriate corrective actions weretaken in accordance with § 120.10. Thisreview shall occur within 1 week (7days) of the day that the records aremade; and

(C) The calibrating of any processmonitoring instruments used at criticalcontrol points and the performance ofany periodic end-product or in-processtesting that is part of the processor’sverification activities. The purpose ofthese reviews shall be, at a minimum, toensure that the records are complete and

that these activities occurred inaccordance with the processor’s writtenprocedures. These reviews shall occurwithin a reasonable time after therecords are made; and

(v) The following of procedures in§ 120.10 whenever any verificationprocedure, including the review ofconsumer complaints, establishes theneed to take a corrective action; and

(vi) Additional process verification ifrequired by § 120.25.

(2) Records that document thecalibration of process monitoringinstruments, in accordance withparagraph (a)(1)(iv)(B) of this section,and the performance of any periodicend-product and in-process testing, inaccordance with paragraph (a)(1)(iv)(C)of this section, are subject to therecordkeeping requirements of § 120.12.

(b) Validation of the HACCP plan.Each processor shall validate that theHACCP plan is adequate to control foodhazards that are reasonably likely tooccur; this validation shall occur at leastonce within 12 months afterimplementation and at least annuallythereafter or whenever any changes inthe process occur that could affect thehazard analysis or alter the HACCP planin any way. Such changes may includechanges in the following: Raw materialsor source of raw materials; productformulation; processing methods orsystems, including computers and theirsoftware; packaging; finished productdistribution systems; or the intendeduse or consumers of the finishedproduct. The validation shall beperformed by an individual orindividuals who have been trained inaccordance with § 120.13 and shall besubject to the recordkeepingrequirements of § 120.12. The HACCPplan shall be modified immediatelywhenever a validation reveals that theplan is no longer adequate to fully meetthe requirements of this part.

(c) Validation of the hazard analysis.Whenever a juice processor has noHACCP plan because a hazard analysishas revealed no food hazards that arereasonably likely to occur, the processorshall reassess the adequacy of thathazard analysis whenever there are anychanges in the process that couldreasonably affect whether a food hazardexists. Such changes may includechanges in the following: Raw materialsor source of raw materials; productformulation; processing methods orsystems, including computers and theirsoftware; packaging; finished productdistribution systems; or the intendeduse or intended consumers of thefinished product. The validation of thehazard analysis shall be performed byan individual or individuals who have

been trained in accordance with§ 120.13, and, records documenting thevalidation shall be subject to therecordkeeping requirements of § 120.12.

§ 120.12 Records.(a) Required records. Each processor

shall maintain the following recordsdocumenting the processor’s HazardAnalysis and Critical Control Point(HACCP) system:

(1) Records documenting theimplementation of the sanitationstandard operating procedures (SSOP’s)(see § 120.6);

(2) The written hazard analysisrequired by § 120.7;

(3) The written HACCP plan requiredby § 120.8;

(4) Records documenting the ongoingapplication of the HACCP plan thatinclude:

(i) Monitoring of critical controlpoints and their critical limits,including the recording of actual times,temperatures, or other measurements, asprescribed in the HACCP plan; and

(ii) Corrective actions, including allactions taken in response to a deviation;and

(5) Records documenting verificationof the HACCP system and validation ofthe HACCP plan or hazard analysis, asappropriate.

(b) General requirements. All recordsrequired by this part shall include:

(1) The name of the processor orimporter and the location of theprocessor or importer, if the processoror importer has more than one location;

(2) The date and time of the activitythat the record reflects, except thatrecords required by paragraphs (a)(2),(a)(3), and (a)(5) of this section need notinclude the time;

(3) The signature or initials of theperson performing the operation orcreating the record; and

(4) Where appropriate, the identity ofthe product and the production code, ifany. Processing and other informationshall be entered on records at the timethat it is observed. The records shallcontain the actual values andobservations obtained duringmonitoring.

(c) Documentation. (1) The records inparagraphs (a)(2) and (a)(3) of thissection shall be signed and dated by themost responsible individual onsite atthe processing facility or by a higherlevel official of the processor. Thesesignatures shall signify that theserecords have been accepted by the firm.

(2) The records in paragraphs (a)(2)and (a)(3) of this section shall be signedand dated:

(i) Upon initial acceptance;(ii) Upon any modification; and



(iii) Upon verification and validationin accordance with § 120.11.

(d) Record retention. (1) All recordsrequired by this part shall be retained atthe processing facility or at theimporter’s place of business in theUnited States for, in the case ofperishable or refrigerated juices, at least1 year after the date that such productswere prepared, and for, in the case offrozen, preserved, or shelf stableproducts, 2 years or the shelf life of theproduct, whichever is greater, after thedate that the products were prepared.

(2) Offsite storage of processingrecords required by paragraphs (a)(1)and (a)(4) of this section is permittedafter 6 months following the date thatthe monitoring occurred, if such recordscan be retrieved and provided onsitewithin 24 hours of request for officialreview. Electronic records areconsidered to be onsite if they areaccessible from an onsite location andcomply with paragraph (g) of thissection.

(3) If the processing facility is closedfor a prolonged period between seasonalpacks, the records may be transferred tosome other reasonably accessiblelocation at the end of the seasonal packbut shall be immediately returned to theprocessing facility for official reviewupon request.

(e) Official review. All recordsrequired by this part shall be availablefor review and copying at reasonabletimes.

(f) Public disclosure. (1) All recordsrequired by this part are not availablefor public disclosure unless they havebeen previously disclosed to the public,as defined in § 20.81 of this chapter, orunless they relate to a product oringredient that has been abandoned andno longer represent a trade secret orconfidential commercial or financialinformation as defined in § 20.61 of thischapter.

(2) Records required to be maintainedby this part are subject to disclosure tothe extent that they are otherwisepublicly available, or that disclosurecould not reasonably be expected tocause a competitive hardship, such asgeneric type HACCP plans that reflectstandard industry practices.

(g) Records maintained on computers.The maintenance of computerizedrecords, in accordance with part 11 ofthis chapter, is acceptable. § 120.13Training.

(a) Only an individual who has metthe requirements of paragraph (b) of thissection shall be responsible for thefollowing functions:

(1) Developing the hazard analysis,including delineating control measures,as required by § 120.7.

(2) Developing a Hazard Analysis andCritical Control Point (HACCP) plan thatis appropriate for a specific processor,in order to meet the requirements of§ 120.8;

(3) Verifying and modifying theHACCP plan in accordance with thecorrective action procedures specifiedin § 120.10(b)(5) and the validationactivities specified in § 120.11(b) and(c); and § 120.7;

(4) Performing the record reviewrequired by § 120.11(a)(1)(iv).

(b) The individual performing thefunctions listed in paragraph (a) of thissection shall have successfullycompleted training in the application ofHACCP principles to juice processing atleast equivalent to that received understandardized curriculum recognized asadequate by the Food and DrugAdministration, or shall be otherwisequalified through job experience toperform these functions. Job experiencemay qualify an individual to performthese functions if such experience hasprovided knowledge at least equivalentto that provided through thestandardized curriculum. The trainedindividual need not be an employee ofthe processor.

§ 120.14 Application of requirements toimported products.

This section sets forth specificrequirements for imported juice.

(a) Importer requirements. Everyimporter of juice shall either:

(1) Obtain the juice from a countrythat has an active memorandum ofunderstanding (MOU) or similaragreement with the Food and DrugAdministration, that covers the food anddocuments the equivalency orcompliance of the inspection system ofthe foreign country with the U.S.system, accurately reflects therelationship between the signing parties,and is functioning and enforceable in itsentirety; or

(2) Have and implement writtenprocedures for ensuring that the juicethat such importer receives for importinto the United States was processed inaccordance with the requirements ofthis part. The procedures shall provide,at a minimum:

(i) Product specifications that aredesigned to ensure that the juice is notadulterated under section 402 of theFederal Food, Drug, and Cosmetic Actbecause it may be injurious to health orbecause it may have been processedunder insanitary conditions; and

(ii) Affirmative steps to ensure thatthe products being offered for entrywere processed under controls that meetthe requirements of this part. Thesesteps may include any of the following:

(A) Obtaining from the foreignprocessor the Hazard Analysis andCritical Control Point (HACCP) plan andprerequisite program of the standardoperating procedure records required bythis part that relate to the specific lot offood being offered for import;

(B) Obtaining either a continuing orlot specific certificate from anappropriate foreign governmentinspection authority or competent thirdparty certifying that the imported foodhas been processed in accordance withthe requirements of this part;

(C) Regularly inspecting the foreignprocessor’s facilities to ensure that theimported food is being processed inaccordance with the requirements ofthis part;

(D) Maintaining on file a copy, inEnglish, of the foreign processor’shazard analysis and HACCP plan, and awritten guarantee from the foreignprocessor that the imported food isprocessed in accordance with therequirements of this part;

(E) Periodically testing the importedfood, and maintaining on file a copy, inEnglish, of a written guarantee from theforeign processor that the imported foodis processed in accordance with therequirements of this part; or

(F) Other such verification measuresas appropriate that provide anequivalent level of assurance ofcompliance with the requirements ofthis part.

(b) Competent third party. Animporter may hire a competent thirdparty to assist with or perform any or allof the verification activities specified inparagraph (a)(2) of this section,including writing the importer’sverification procedures on theimporter’s behalf.

(c) Records. The importer shallmaintain records, in English, thatdocument the performance and resultsof the affirmative steps specified inparagraph (a)(2)(ii) of this section. Theserecords shall be subject to the applicableprovisions of § 120.12.

(d) Determination of compliance. Theimporter shall provide evidence that alljuice offered for entry into the UnitedStates has been processed underconditions that comply with this part. Ifassurances do not exist that an importedjuice has been processed underconditions that are equivalent to thoserequired of domestic processors underthis part, the product will appear to beadulterated and will be denied entry.



Subpart B—Pathogen Reduction

§ 120.20 General.

This subpart augments subpart A ofthis part by setting forth specificrequirements for process controls.

§ 120.24 Process controls.

(a) In order to meet the requirementsof subpart A of this part, processors ofjuice products shall include in theirHazard Analysis and Critical ControlPoint (HACCP) plans control measuresthat will consistently produce, at aminimum, a 5 log (i.e., 105) reduction,for a period at least as long as the shelflife of the product when stored undernormal and moderate abuse conditions,in the pertinent microorganism. For thepurposes of this regulation, the‘‘pertinent microorganism’’ is the mostresistant microorganism of public healthsignificance that is likely to occur in thejuice. The following juice processors areexempt from this paragraph:

(1) A juice processor that is subject tothe requirements of part 113 or part 114of this chapter; and

(2) A juice processor using a singlethermal processing step sufficient toachieve shelf-stability of the juice or athermal concentration process thatincludes thermal treatment of allingredients, provided that the processorincludes a copy of the thermal processused to achieve shelf-stability orconcentration in its written hazardanalysis required by § 120.7.

(b) All juice processors shall meet therequirements of paragraph (a) of thissection through treatments that areapplied directly to the juice, except thatcitrus juice processors may usetreatments to fruit surfaces, providedthat the 5-log reduction process beginsafter culling and cleaning as defined in§ 120.3(a) and (f) and the reduction isaccomplished within a singleproduction facility.

(c) All juice processors shall meet therequirements of paragraphs (a) and (b) ofthis section and perform final productpackaging within a single productionfacility operating under current goodmanufacturing practices. Processorsclaiming an exemption under paragraph(a)(1) or (a)(2) of this section shall alsoprocess and perform final productpackaging of all juice subject to theclaimed exemption within a singleproduction facility operating undercurrent good manufacturing practices.

§ 120.25 Process verification for certainprocessors.

Each juice processor that relies ontreatments that do not come into directcontact with all parts of the juice toachieve the requirements of § 120.24shall analyze the finished product forbiotype I Escherichia coli as follows:

(a) One 20 milliliter (mL) sample(consisting of two 10 mL subsamples)for each 1,000 gallons of juice producedshall be sampled each production day.If less than 1,000 gallons of juice isproduced per day, the sample must betaken for each 1,000 gallons producedbut not less than once every 5 workingdays that the facility is producing thatjuice. Each subsample shall be taken byrandomly selecting a package of juiceready for distribution to consumers.

(b) If the facility is producing morethan one type of juice covered by thissection, processors shall takesubsamples according to paragraph (a)of this section for each of the coveredjuice products produced.

(c) Processors shall analyze eachsubsample for the presence of E. coli bythe method entitled ‘‘Analysis forEscherichia coli in Citrus Juices—Modification of AOAC Official Method992.30’’ or another method that is atleast equivalent to this method in termsof accuracy, precision, and sensitivity indetecting E. coli. This method isdesigned to detect the presence orabsence of E. coli in a 20 mL sample ofjuice (consisting of two 10 mLsubsamples). The method is as follows:

(1) Sample size. Total-20 mL of juice;perform analysis using two 10 mLaliquots.

(2) Media. Universal PreenrichmentBroth (Difco, Detroit, MI), EC Broth(various manufacturers).

(3) Method. ColiComplete (AOACOfficial Method 992.30—modified).

(4) Procedure. Perform the followingprocedure two times:

(i) Aseptically inoculate 10 mL ofjuice into 90 mL of UniversalPreenrichment Broth (Difco) andincubate at 35 °C for 18 to 24 hours.

(ii) Next day, transfer 1 mL ofpreenriched sample into 10 mL of ECBroth, without durham gas vials. Afterinoculation, aseptically add aColiComplete SSD disc into each tube.

(iii) Incubate at 44.5 °C for 18 to 24hours.

(iv) Examine the tubes underlongwave ultra violet light (366 nm).Fluorescent tubes indicate presence ofE. coli.

(v) MUG positive and negativecontrols should be used as reference ininterpreting fluorescence reactions. Usean E. coli for positive control and 2negative controls—a MUG negativestrain and an uninoculated tube media.

(d) If either 10 mL subsample ispositive for E. coli, the 20 mL sample isrecorded as positive and the processorshall:

(1) Review monitoring records for thecontrol measures to attain the 5-logreduction standard and correct thoseconditions and practices that are notmet. In addition, the processor maychoose to test the sample for thepresence of pathogens of concern.

(2) If the review of monitoring recordsor the additional testing indicates thatthe 5-log reduction standard was notachieved (e.g., a sample is found to bepositive for the presence of a pathogenor a deviation in the process or itsdelivery is identified), the processorshall take corrective action as set forthin § 120.10.

(e) If two samples in a series of seventests are positive for E. coli, the controlmeasures to attain the 5-log reductionstandard shall be deemed to beinadequate and the processor shallimmediately:

(1) Until corrective actions arecompleted, use an alternative process orprocesses that achieve the 5-logreduction after the juice has beenexpressed;

(2) Perform a review of the monitoringrecords for control measures to attainthe 5-log reduction standard. Thereview shall be sufficiently extensive todetermine that there are no trendstowards loss of control;

(i) If the conditions and practices arenot being met, correct those that do notconform to the HACCP plan; or

(ii) If the conditions and practices arebeing met, the processor shall validatethe HACCP plan in relation to the 5-logreduction standard; and

(3) Take corrective action as set forthin § 120.10. Corrective actions shallinclude ensuring no product enterscommerce that is injurious to health asset forth in § 120.10(a)(1).

Dated: December 20, 2000.Jane E. Henny,Commissioner of Food and Drugs.Donna E. Shalala,Secretary of Health and Human Services.[FR Doc. 01–1291 Filed 1–18–01; 8:45 am]BILLING CODE 4160–01–P


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Department of Health and Human Services - GPO 19, 2001 · Department of Health and Human Services ... Operating Procedures D. Hazard Analysis ... processing of citrus juice and juice